EMPLOYEE(SJ SIGNATURE SEE REVERSE Ademola 0. Dara mo 1a , Inv est igator" OF THIS PAGE Binh T . Nguyen , Investigator ) DATE ISSUED 08/25/2014 FORM (0'1/1)8) I,KEVIOU::i {;JJIII()N OUS()t l:-1 1: 08SERVATIONS P,\Gf: l OF PAGF.S OEf>ARTI\IENT OJi Ht:AI.HI ANO Jill MAN SERVIG:S FOOl> 1\NIJ ORUG AOM INISTRATION DISTRICT ADDRESS liND PHONE NU M BER DATE(S) OF INSPECTION 197 01 Fairchild 08/ 18 /2014 - 08/25/2014 FEINUMBER Irv ine , CA 92612 (94 9) 608-2900 Fax : (94 9) 608-4 417 3004600090 I ndustry Information : www.fda . gov/oc/ i ndus tr y NAME ANO TITLE OF INOlVI Il,J. \l 10 WliOM REPOR!ISSUED TO: Mr . Glen A. Ol sheim, Ch i ef Op era ting Off i cer !liREEl ADDRESS Californ i a Pha rmacy & c ompou n di ng Cent e r 4000 Birch St Ste 1 20 CITY, STATE. ZIP COD€ . COUNTRY OYPE ESTA.8U SHI.<ENT INSPECTED Newport Beach, CA 92660-2258 503 8 Ou ts o ur c i ng Facility This document lists observations made by the FDA rcpresentative(s) duri ng the inspect i on of your tacility. They are inspcctional ohsen·ations, and do not represent a tinal Agency determ ination regarding your compliance. If you have an objection regarding an observation. or have implemented. or plan to implement. corrective action in response to an observation, you may discuss the object ion or action wi th the FDA rc presentati ve(s) during the inspl!ction or s ubmit t his in fo rmation to FDA at the address above. If you have any questions, please contact FDA at the phone number and add ress above. DURING AN INSPECTION OF YOUR FIRM WE OBSERVED: Facilities and Equipment System OBSERVATION 1 Aseptic process ing areas are deficient regarding the system for monitoring environmental conditions. Specifically, A. Your firm failed to conduct environmental monitoring of air, personnel and surface duri ng daily production periods, within the ISO 7 clean room and ISO 5 laminar flow hoods used to prepare your sterile drug products. For example: 111 a) During the period covering March 21sr 2014 to June 19 2014, no environmental monitoring of air, personnel, or surface was performed by your tirm. During this period, an average number of - sterile formulations were compounded, filled and released from your facility per day. 1 1 b) During the period of January 26 h 2014 to March 19 h 2014, no environmental monitoring of air, personnel, or surface was performed by your firm. During this period, approximately IIi sterile formulations were compounded, tilled, and released from your facility per day. B. Your tirm does not monitor personnel and environmental bio-burden within your sterile processing facility during production periods. For example: a) Your firm does not perform microbiological sampling of personnel gowns worn by pharmacists and technicians that process drug products intended to be sterile in aseptic processing areas. On 8/ 18/20l4, we reviewed environmental monitoring records that
Transcript
EMPLOYEE(SJ SIGNATURE
SEE REVERSE Ademola 0 Daramo 1a Invest igator
OF THIS PAGE Binh T Nguyen Investigator
~ )
DATE ISSUED
08252014
FORM ~II ~83 (011)8) IKEVIOUi JJIII()N OUS()t l-1 1 INSPI~CTIONAL 08SERVATIONS PGf l OF I ~ PAGFS
DISTRICT ADDRESS liND PHONE NUM BER DATE(S) OF INSPECTION
197 01 Fairchild 08182014 - 08252014 FEINUMBER Irvine CA 92612
(94 9) 608-2900 Fax (94 9) 608-4 417 3004600090 I ndustry Information wwwfda govoc i ndus try NAME ANO TITLE OF INOlVIIlJl10WliOM REPORISSUED
TO Mr Glen A Ol sheim Ch i ef Operating Offi cer FIMHI~gt liREEl ADDRESS
Californi a Pharmacy amp c ompou ndi ng Cente r 4000 Birch St Ste 120 CITY STATE ZIP CODeuro COUNTRY OYPE ESTA8U SHIltENT INSPECTED
Newport Beach CA 92660-2258 5038 Outsourc i ng Facility
This document lists observations made by the FDA rcpresentative(s) during the inspection of your tacility They are inspcctional ohsenmiddotations and do not represent a tinal Agency determination regarding your compliance If you have an objection regarding an observation or have implemented or plan to implement corrective action in response to an observation you may discuss the objection or action with the FDA rcpresentative(s) during the insplction or submit this information to FDA at the address above If you have any questions please contact FDA at the phone number and add ress above
DURING AN INSPECTION OF YOUR FIRM WE OBSERVED
Facilities and Equipment System
OBSERVATION 1
Aseptic process ing areas are deficient regarding the system for monitoring environmental conditions
Specifically
A Your firm failed to conduct environmental monitoring of air personnel and surface during daily production periods within the ISO 7 clean room and ISO 5 laminar flow hoods used to prepare your sterile drug products For example
111 a) During the period covering March 21sr 2014 to June 19 2014 no environmental monitoring of air personnel or surface was performed by your tirm During this period an average number of - sterile formulations were compounded filled and released from your facility per day
1 1 b) During the period of January 26 h 2014 to March 19 h 2014 no environmental monitoring of air personnel or surface was performed by your firm During this period approximately IIi sterile formulations were compounded tilled and released from your facility per day
B Your tirm does not monitor personnel and environmental bio-burden within your sterile processing facility during production periods For example
a) Your firm does not perform microbiological sampling of personnel gowns worn by pharmacists and technicians that process drug products intended to be sterile in aseptic processing areas On 8 1820l4 we reviewed environmental monitoring records that
FORM mA48J PREVK)US EOi l iON OOSOLETE INSPECTIO NAL OIJSE RVA TIONS PAGE 2 OF IJ AGES
08252014
Ne
OEPA
-
3004600090
t Beach CA 92660- 2258 5038 Outs
indicated results of finger tips sampling but no other portion of the operators (such as arms and chest) who performed aseptic manipulations was tested Your chief operating officer stated that there were no other samples collected to monitor the microbial load of gowns worn by operators in the aseptic processing areas Additionally operators fi nger-tips are tested of aseptic process not after production and testing is not performed for microbial contamination at least daily but The written procedure which guides the gloved fingertip sampling AWl 430 titled Area Work Instruction Gloved Fingertip Sampling Procedure does not have a defined frequency for sampling and testing of personnel finger tips as well as monitoring other areas such as arms chests and masks
b) There are ~0 5 LFH (laminar flow hood) located in ISO 7 area LFHs are used onaJII basis However your firm does not perform environmental monitoring of these LFHs at least on a Ill basis Your firm performed environmental monitoring of work surfaces as follows per SOP A WI 160 titled Area Work Instruction (A WI) Environmental Monitoring Procedure
a On 07118114 LFH was surface-tested using b On 072514 LFH was surface-tested c On 080214 L FH was surface-tested using d On 0809 14 LFH was surface-tested using e On 08lS14 LFH was surface-tested usi ng
section 52 states Samples are collecte~ usin media Each of media is used on
This SOP does not spect
OBSERVATION 2
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products
Specifically A Storage of sterilized stoppers (inside ISO 8 room) and conditions of reuse may pose
contamination risks Previously sterilized rubber stoppers used as container closure for your
Ademola 0 Daramola InvestigatorSEE REVERSE
08252014Blnh T Nguyen Investigator ~ OF THIS PAGE
FORM Ill ~8J PAGE J OF 13
0825201 4 -
3004600090
92660- 2258
sterile products are loaded into totes and stored inside the ISO 8 ante room for upwards o - middot Th~ storage date is arbitrarily assigned with no scientific justification Prior to use inside the clean room the sterility and endotoxin of these stoppers are not verified The tote bags are removed from the ante room and moved into the clean room where the tote bag is opened under ISO 5 Once open the bag is left open on the LAF work surface foshy- allowing the employee to make repeated retrieval of rubber stoppers from the bag based on the batch size of product being manufactured before resealing the bag and returned to the ISO 8 location This process is repeated several times on different production days until the tote bag is emptied The rubber stoppers are immediate contact surfaces for the sterile products and the process of opening the tote bag several times and picking out rubber stoppers before being stored under ISO 8 conditions may pose a contamination risk to the product For example this same lot of serum bottle stopper was used in the capping of the following drug products
B Your firm does not perform closure container integrity test to verify that your products are adequately protected from leaks and ingress of microorganisms For example your firm uses a
(b) (4) seal finished roduct vials
OBSERVATION 3
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient
Speci fically your clean room design is deficient to prevent product contamination For example
A The air exhaust vents located in your ISO 7 and ISO 8 cleanrooms open into a non-classified area of the facility On 8182014 we observed that the modular clean rooms have air exhaust vents located on the base of the wall The air vents directly to the unclassified
DFPARliIENT OF HEALTil AND Jlllll1i SERV ICES fOOD AND OfWO 1DMI Nilgtl iV l iON
environment sunounding the clean room increasing the potential for air exchanges between the ISO 7 and ISO 8 cleanrooms and the non-classified environment and an intlux of contamination from the unclassified area of low air quality into the clean room due to the lack of proper air pressurization (there is no pressure differential monitoring between the c lassified and unclassified areas as well as between ISO 7 and ISO 8 areas) Additionally there is no program in place for pest monitoring at the facility
B The exhaust vents located in the ISO 7 cleanroom were partially blocked by a metal table obstructing air flowreturn On 81820 14 we observed th at the air vents exhaust located on the base of the wall directly opposite the laminar flow hood inside your ISO 7 clean room were obstructed by a silver colored metal table which held tote bags and sterile components used in the production of your sterile drug products The blockage o f the air exhaust vents may pose a potential risk of airflow turbulences inside the - ISO 5 laminar flow hoods located inside this ISO 7 clean room
(b)i4)c pressure gauges used to monitor air pressure of ISO 7 and ISO 8 clean
rooms
D There is no documented unidirectional air flow between ISO 5 work benches where aseptic manipulation of drug products occurs and room spaces classified as ISO 7 areas
111 Additionally smoke studies conducted on March 20 2014 show turbulent and stagnant air within ISO 5 areas used to steril ize and fill dmg product unit containers
OBSERVATION 4
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Specifically The frequency of cleaning and disinfection of your c leanroom is inadequate for the operations being performed Your firm compounds an average of of sterile drug products daily but the clean rooms (walls and cleaned with non-sterile germicidal solutions such as Your not use any sporicidal cleaning agent to clean the ISO 5 environment Assurance Director the I ISO
ib)i4)5 hoods arc cleaned wit~n at least compounding batch but the
DEPARTMENT OF IIEAJ nt ANO HUMA~ SERVICES FOOD AND DRUG Algtt-IINISI RA l iON
DISTRICTADDRESS AND PHONE NUMBER OATE(S) OF INSPECnON
19701 Fairchild 08182014 - 08252014 FEINUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608 - 4417 3004600090 Industry Information wwwfdagovocindustry
TO Mr Glen A Olsheim Chief Operating Officer F IRM NAME
California Pharmacy amp Compounding Center CITY STATE ZIP CODE COUIHRY
Newport Beach CA 92660-2258
STREET AOORE$
1000 Birch SL Ste 120 TYPE ESTABLI SHMENT INSPECTED
5038 Outsourcing Facil i t
firm does not have any cleanin rocedure for ISO 5 hood in lace yet
OBSERVATION 5
Equipment used in the manufacture processing packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended use
Specifically
(b) (4)A Your firm has not conducted equipment qualification to show that ( b )(4 ) used to sterilize rubber stoppers a
used to de-pyrogenate glassware achieve appropriate log of microbes Your does not use any BI (biological indicator) during the
sterilization of glassware and closure (rubber stoppers) - sterilization of finished products by is done at while glassware and rubber stoppers arc
(b) (4) sterilized in the for Your firm only conducts ofthe - (not
B Your firm has not validated sterilization method used to sterilize glass vials and rubber stoppers used in the storage of sterile drug products to ensure sterility of glass vials and rubber stoppers
OBSERVATION 6
Clothing of personnel engaged in the manufacturing processing and holding ofdrug products is not appropriate for the duties they perform
Specifically gowning for steri le operation is inadequate in that
A Non-sterile face masks hair nets and shoe covers are worn during aseptic processing of sterile drug production in the ISO 5 horizontal laminar air flow hoods
B Street scrubs are worn covered wit h sterile gown but the scrubs are still exposed during production of sterile products
EMPLOYEE IS) SIGNATURE DATE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE
Sinh T Nguyen Investigator 082S2014OF THIS PAGE
FORM fl) 483 (09081 PREVIOUS EDITION 06SOLETE INSIECrJONAL 06SERVATIONS PAGE 5 OF IJ PAG~S
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
FORM mA48J PREVK)US EOi l iON OOSOLETE INSPECTIO NAL OIJSE RVA TIONS PAGE 2 OF IJ AGES
08252014
Ne
OEPA
-
3004600090
t Beach CA 92660- 2258 5038 Outs
indicated results of finger tips sampling but no other portion of the operators (such as arms and chest) who performed aseptic manipulations was tested Your chief operating officer stated that there were no other samples collected to monitor the microbial load of gowns worn by operators in the aseptic processing areas Additionally operators fi nger-tips are tested of aseptic process not after production and testing is not performed for microbial contamination at least daily but The written procedure which guides the gloved fingertip sampling AWl 430 titled Area Work Instruction Gloved Fingertip Sampling Procedure does not have a defined frequency for sampling and testing of personnel finger tips as well as monitoring other areas such as arms chests and masks
b) There are ~0 5 LFH (laminar flow hood) located in ISO 7 area LFHs are used onaJII basis However your firm does not perform environmental monitoring of these LFHs at least on a Ill basis Your firm performed environmental monitoring of work surfaces as follows per SOP A WI 160 titled Area Work Instruction (A WI) Environmental Monitoring Procedure
a On 07118114 LFH was surface-tested using b On 072514 LFH was surface-tested c On 080214 L FH was surface-tested using d On 0809 14 LFH was surface-tested using e On 08lS14 LFH was surface-tested usi ng
section 52 states Samples are collecte~ usin media Each of media is used on
This SOP does not spect
OBSERVATION 2
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products
Specifically A Storage of sterilized stoppers (inside ISO 8 room) and conditions of reuse may pose
contamination risks Previously sterilized rubber stoppers used as container closure for your
Ademola 0 Daramola InvestigatorSEE REVERSE
08252014Blnh T Nguyen Investigator ~ OF THIS PAGE
FORM Ill ~8J PAGE J OF 13
0825201 4 -
3004600090
92660- 2258
sterile products are loaded into totes and stored inside the ISO 8 ante room for upwards o - middot Th~ storage date is arbitrarily assigned with no scientific justification Prior to use inside the clean room the sterility and endotoxin of these stoppers are not verified The tote bags are removed from the ante room and moved into the clean room where the tote bag is opened under ISO 5 Once open the bag is left open on the LAF work surface foshy- allowing the employee to make repeated retrieval of rubber stoppers from the bag based on the batch size of product being manufactured before resealing the bag and returned to the ISO 8 location This process is repeated several times on different production days until the tote bag is emptied The rubber stoppers are immediate contact surfaces for the sterile products and the process of opening the tote bag several times and picking out rubber stoppers before being stored under ISO 8 conditions may pose a contamination risk to the product For example this same lot of serum bottle stopper was used in the capping of the following drug products
B Your firm does not perform closure container integrity test to verify that your products are adequately protected from leaks and ingress of microorganisms For example your firm uses a
(b) (4) seal finished roduct vials
OBSERVATION 3
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient
Speci fically your clean room design is deficient to prevent product contamination For example
A The air exhaust vents located in your ISO 7 and ISO 8 cleanrooms open into a non-classified area of the facility On 8182014 we observed that the modular clean rooms have air exhaust vents located on the base of the wall The air vents directly to the unclassified
DFPARliIENT OF HEALTil AND Jlllll1i SERV ICES fOOD AND OfWO 1DMI Nilgtl iV l iON
environment sunounding the clean room increasing the potential for air exchanges between the ISO 7 and ISO 8 cleanrooms and the non-classified environment and an intlux of contamination from the unclassified area of low air quality into the clean room due to the lack of proper air pressurization (there is no pressure differential monitoring between the c lassified and unclassified areas as well as between ISO 7 and ISO 8 areas) Additionally there is no program in place for pest monitoring at the facility
B The exhaust vents located in the ISO 7 cleanroom were partially blocked by a metal table obstructing air flowreturn On 81820 14 we observed th at the air vents exhaust located on the base of the wall directly opposite the laminar flow hood inside your ISO 7 clean room were obstructed by a silver colored metal table which held tote bags and sterile components used in the production of your sterile drug products The blockage o f the air exhaust vents may pose a potential risk of airflow turbulences inside the - ISO 5 laminar flow hoods located inside this ISO 7 clean room
(b)i4)c pressure gauges used to monitor air pressure of ISO 7 and ISO 8 clean
rooms
D There is no documented unidirectional air flow between ISO 5 work benches where aseptic manipulation of drug products occurs and room spaces classified as ISO 7 areas
111 Additionally smoke studies conducted on March 20 2014 show turbulent and stagnant air within ISO 5 areas used to steril ize and fill dmg product unit containers
OBSERVATION 4
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Specifically The frequency of cleaning and disinfection of your c leanroom is inadequate for the operations being performed Your firm compounds an average of of sterile drug products daily but the clean rooms (walls and cleaned with non-sterile germicidal solutions such as Your not use any sporicidal cleaning agent to clean the ISO 5 environment Assurance Director the I ISO
ib)i4)5 hoods arc cleaned wit~n at least compounding batch but the
DEPARTMENT OF IIEAJ nt ANO HUMA~ SERVICES FOOD AND DRUG Algtt-IINISI RA l iON
DISTRICTADDRESS AND PHONE NUMBER OATE(S) OF INSPECnON
19701 Fairchild 08182014 - 08252014 FEINUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608 - 4417 3004600090 Industry Information wwwfdagovocindustry
TO Mr Glen A Olsheim Chief Operating Officer F IRM NAME
California Pharmacy amp Compounding Center CITY STATE ZIP CODE COUIHRY
Newport Beach CA 92660-2258
STREET AOORE$
1000 Birch SL Ste 120 TYPE ESTABLI SHMENT INSPECTED
5038 Outsourcing Facil i t
firm does not have any cleanin rocedure for ISO 5 hood in lace yet
OBSERVATION 5
Equipment used in the manufacture processing packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended use
Specifically
(b) (4)A Your firm has not conducted equipment qualification to show that ( b )(4 ) used to sterilize rubber stoppers a
used to de-pyrogenate glassware achieve appropriate log of microbes Your does not use any BI (biological indicator) during the
sterilization of glassware and closure (rubber stoppers) - sterilization of finished products by is done at while glassware and rubber stoppers arc
(b) (4) sterilized in the for Your firm only conducts ofthe - (not
B Your firm has not validated sterilization method used to sterilize glass vials and rubber stoppers used in the storage of sterile drug products to ensure sterility of glass vials and rubber stoppers
OBSERVATION 6
Clothing of personnel engaged in the manufacturing processing and holding ofdrug products is not appropriate for the duties they perform
Specifically gowning for steri le operation is inadequate in that
A Non-sterile face masks hair nets and shoe covers are worn during aseptic processing of sterile drug production in the ISO 5 horizontal laminar air flow hoods
B Street scrubs are worn covered wit h sterile gown but the scrubs are still exposed during production of sterile products
EMPLOYEE IS) SIGNATURE DATE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE
Sinh T Nguyen Investigator 082S2014OF THIS PAGE
FORM fl) 483 (09081 PREVIOUS EDITION 06SOLETE INSIECrJONAL 06SERVATIONS PAGE 5 OF IJ PAG~S
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
Ademola 0 Daramola InvestigatorSEE REVERSE
08252014Blnh T Nguyen Investigator ~ OF THIS PAGE
FORM Ill ~8J PAGE J OF 13
0825201 4 -
3004600090
92660- 2258
sterile products are loaded into totes and stored inside the ISO 8 ante room for upwards o - middot Th~ storage date is arbitrarily assigned with no scientific justification Prior to use inside the clean room the sterility and endotoxin of these stoppers are not verified The tote bags are removed from the ante room and moved into the clean room where the tote bag is opened under ISO 5 Once open the bag is left open on the LAF work surface foshy- allowing the employee to make repeated retrieval of rubber stoppers from the bag based on the batch size of product being manufactured before resealing the bag and returned to the ISO 8 location This process is repeated several times on different production days until the tote bag is emptied The rubber stoppers are immediate contact surfaces for the sterile products and the process of opening the tote bag several times and picking out rubber stoppers before being stored under ISO 8 conditions may pose a contamination risk to the product For example this same lot of serum bottle stopper was used in the capping of the following drug products
B Your firm does not perform closure container integrity test to verify that your products are adequately protected from leaks and ingress of microorganisms For example your firm uses a
(b) (4) seal finished roduct vials
OBSERVATION 3
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient
Speci fically your clean room design is deficient to prevent product contamination For example
A The air exhaust vents located in your ISO 7 and ISO 8 cleanrooms open into a non-classified area of the facility On 8182014 we observed that the modular clean rooms have air exhaust vents located on the base of the wall The air vents directly to the unclassified
DFPARliIENT OF HEALTil AND Jlllll1i SERV ICES fOOD AND OfWO 1DMI Nilgtl iV l iON
environment sunounding the clean room increasing the potential for air exchanges between the ISO 7 and ISO 8 cleanrooms and the non-classified environment and an intlux of contamination from the unclassified area of low air quality into the clean room due to the lack of proper air pressurization (there is no pressure differential monitoring between the c lassified and unclassified areas as well as between ISO 7 and ISO 8 areas) Additionally there is no program in place for pest monitoring at the facility
B The exhaust vents located in the ISO 7 cleanroom were partially blocked by a metal table obstructing air flowreturn On 81820 14 we observed th at the air vents exhaust located on the base of the wall directly opposite the laminar flow hood inside your ISO 7 clean room were obstructed by a silver colored metal table which held tote bags and sterile components used in the production of your sterile drug products The blockage o f the air exhaust vents may pose a potential risk of airflow turbulences inside the - ISO 5 laminar flow hoods located inside this ISO 7 clean room
(b)i4)c pressure gauges used to monitor air pressure of ISO 7 and ISO 8 clean
rooms
D There is no documented unidirectional air flow between ISO 5 work benches where aseptic manipulation of drug products occurs and room spaces classified as ISO 7 areas
111 Additionally smoke studies conducted on March 20 2014 show turbulent and stagnant air within ISO 5 areas used to steril ize and fill dmg product unit containers
OBSERVATION 4
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Specifically The frequency of cleaning and disinfection of your c leanroom is inadequate for the operations being performed Your firm compounds an average of of sterile drug products daily but the clean rooms (walls and cleaned with non-sterile germicidal solutions such as Your not use any sporicidal cleaning agent to clean the ISO 5 environment Assurance Director the I ISO
ib)i4)5 hoods arc cleaned wit~n at least compounding batch but the
DEPARTMENT OF IIEAJ nt ANO HUMA~ SERVICES FOOD AND DRUG Algtt-IINISI RA l iON
DISTRICTADDRESS AND PHONE NUMBER OATE(S) OF INSPECnON
19701 Fairchild 08182014 - 08252014 FEINUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608 - 4417 3004600090 Industry Information wwwfdagovocindustry
TO Mr Glen A Olsheim Chief Operating Officer F IRM NAME
California Pharmacy amp Compounding Center CITY STATE ZIP CODE COUIHRY
Newport Beach CA 92660-2258
STREET AOORE$
1000 Birch SL Ste 120 TYPE ESTABLI SHMENT INSPECTED
5038 Outsourcing Facil i t
firm does not have any cleanin rocedure for ISO 5 hood in lace yet
OBSERVATION 5
Equipment used in the manufacture processing packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended use
Specifically
(b) (4)A Your firm has not conducted equipment qualification to show that ( b )(4 ) used to sterilize rubber stoppers a
used to de-pyrogenate glassware achieve appropriate log of microbes Your does not use any BI (biological indicator) during the
sterilization of glassware and closure (rubber stoppers) - sterilization of finished products by is done at while glassware and rubber stoppers arc
(b) (4) sterilized in the for Your firm only conducts ofthe - (not
B Your firm has not validated sterilization method used to sterilize glass vials and rubber stoppers used in the storage of sterile drug products to ensure sterility of glass vials and rubber stoppers
OBSERVATION 6
Clothing of personnel engaged in the manufacturing processing and holding ofdrug products is not appropriate for the duties they perform
Specifically gowning for steri le operation is inadequate in that
A Non-sterile face masks hair nets and shoe covers are worn during aseptic processing of sterile drug production in the ISO 5 horizontal laminar air flow hoods
B Street scrubs are worn covered wit h sterile gown but the scrubs are still exposed during production of sterile products
EMPLOYEE IS) SIGNATURE DATE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE
Sinh T Nguyen Investigator 082S2014OF THIS PAGE
FORM fl) 483 (09081 PREVIOUS EDITION 06SOLETE INSIECrJONAL 06SERVATIONS PAGE 5 OF IJ PAG~S
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DFPARliIENT OF HEALTil AND Jlllll1i SERV ICES fOOD AND OfWO 1DMI Nilgtl iV l iON
environment sunounding the clean room increasing the potential for air exchanges between the ISO 7 and ISO 8 cleanrooms and the non-classified environment and an intlux of contamination from the unclassified area of low air quality into the clean room due to the lack of proper air pressurization (there is no pressure differential monitoring between the c lassified and unclassified areas as well as between ISO 7 and ISO 8 areas) Additionally there is no program in place for pest monitoring at the facility
B The exhaust vents located in the ISO 7 cleanroom were partially blocked by a metal table obstructing air flowreturn On 81820 14 we observed th at the air vents exhaust located on the base of the wall directly opposite the laminar flow hood inside your ISO 7 clean room were obstructed by a silver colored metal table which held tote bags and sterile components used in the production of your sterile drug products The blockage o f the air exhaust vents may pose a potential risk of airflow turbulences inside the - ISO 5 laminar flow hoods located inside this ISO 7 clean room
(b)i4)c pressure gauges used to monitor air pressure of ISO 7 and ISO 8 clean
rooms
D There is no documented unidirectional air flow between ISO 5 work benches where aseptic manipulation of drug products occurs and room spaces classified as ISO 7 areas
111 Additionally smoke studies conducted on March 20 2014 show turbulent and stagnant air within ISO 5 areas used to steril ize and fill dmg product unit containers
OBSERVATION 4
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions
Specifically The frequency of cleaning and disinfection of your c leanroom is inadequate for the operations being performed Your firm compounds an average of of sterile drug products daily but the clean rooms (walls and cleaned with non-sterile germicidal solutions such as Your not use any sporicidal cleaning agent to clean the ISO 5 environment Assurance Director the I ISO
ib)i4)5 hoods arc cleaned wit~n at least compounding batch but the
DEPARTMENT OF IIEAJ nt ANO HUMA~ SERVICES FOOD AND DRUG Algtt-IINISI RA l iON
DISTRICTADDRESS AND PHONE NUMBER OATE(S) OF INSPECnON
19701 Fairchild 08182014 - 08252014 FEINUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608 - 4417 3004600090 Industry Information wwwfdagovocindustry
TO Mr Glen A Olsheim Chief Operating Officer F IRM NAME
California Pharmacy amp Compounding Center CITY STATE ZIP CODE COUIHRY
Newport Beach CA 92660-2258
STREET AOORE$
1000 Birch SL Ste 120 TYPE ESTABLI SHMENT INSPECTED
5038 Outsourcing Facil i t
firm does not have any cleanin rocedure for ISO 5 hood in lace yet
OBSERVATION 5
Equipment used in the manufacture processing packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended use
Specifically
(b) (4)A Your firm has not conducted equipment qualification to show that ( b )(4 ) used to sterilize rubber stoppers a
used to de-pyrogenate glassware achieve appropriate log of microbes Your does not use any BI (biological indicator) during the
sterilization of glassware and closure (rubber stoppers) - sterilization of finished products by is done at while glassware and rubber stoppers arc
(b) (4) sterilized in the for Your firm only conducts ofthe - (not
B Your firm has not validated sterilization method used to sterilize glass vials and rubber stoppers used in the storage of sterile drug products to ensure sterility of glass vials and rubber stoppers
OBSERVATION 6
Clothing of personnel engaged in the manufacturing processing and holding ofdrug products is not appropriate for the duties they perform
Specifically gowning for steri le operation is inadequate in that
A Non-sterile face masks hair nets and shoe covers are worn during aseptic processing of sterile drug production in the ISO 5 horizontal laminar air flow hoods
B Street scrubs are worn covered wit h sterile gown but the scrubs are still exposed during production of sterile products
EMPLOYEE IS) SIGNATURE DATE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE
Sinh T Nguyen Investigator 082S2014OF THIS PAGE
FORM fl) 483 (09081 PREVIOUS EDITION 06SOLETE INSIECrJONAL 06SERVATIONS PAGE 5 OF IJ PAG~S
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DEPARTMENT OF IIEAJ nt ANO HUMA~ SERVICES FOOD AND DRUG Algtt-IINISI RA l iON
DISTRICTADDRESS AND PHONE NUMBER OATE(S) OF INSPECnON
19701 Fairchild 08182014 - 08252014 FEINUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608 - 4417 3004600090 Industry Information wwwfdagovocindustry
TO Mr Glen A Olsheim Chief Operating Officer F IRM NAME
California Pharmacy amp Compounding Center CITY STATE ZIP CODE COUIHRY
Newport Beach CA 92660-2258
STREET AOORE$
1000 Birch SL Ste 120 TYPE ESTABLI SHMENT INSPECTED
5038 Outsourcing Facil i t
firm does not have any cleanin rocedure for ISO 5 hood in lace yet
OBSERVATION 5
Equipment used in the manufacture processing packing or holding ofdrug products is not of appropriate design to facilitate operations for its intended use
Specifically
(b) (4)A Your firm has not conducted equipment qualification to show that ( b )(4 ) used to sterilize rubber stoppers a
used to de-pyrogenate glassware achieve appropriate log of microbes Your does not use any BI (biological indicator) during the
sterilization of glassware and closure (rubber stoppers) - sterilization of finished products by is done at while glassware and rubber stoppers arc
(b) (4) sterilized in the for Your firm only conducts ofthe - (not
B Your firm has not validated sterilization method used to sterilize glass vials and rubber stoppers used in the storage of sterile drug products to ensure sterility of glass vials and rubber stoppers
OBSERVATION 6
Clothing of personnel engaged in the manufacturing processing and holding ofdrug products is not appropriate for the duties they perform
Specifically gowning for steri le operation is inadequate in that
A Non-sterile face masks hair nets and shoe covers are worn during aseptic processing of sterile drug production in the ISO 5 horizontal laminar air flow hoods
B Street scrubs are worn covered wit h sterile gown but the scrubs are still exposed during production of sterile products
EMPLOYEE IS) SIGNATURE DATE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE
Sinh T Nguyen Investigator 082S2014OF THIS PAGE
FORM fl) 483 (09081 PREVIOUS EDITION 06SOLETE INSIECrJONAL 06SERVATIONS PAGE 5 OF IJ PAG~S
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DEPARTMENT OF IIEALTH AND HliMAN SERVICES FOOD AND DRUG ADMINISTR ATION
DISTRICT ADDRESS AND PHONE NUMBER OA TE(S) OF INSPECTION
19701 fairchild 08182014 - 08252014 FElNUMBERI rvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry
TO tltlr Glen A Olsheim Chief 0 erating Officer f i AAHIAMS
California Pharmacy amp Compounding Center CllY STATE ZP CODE COIJNTRY
Newport Beach CA 92660-2258
SlREEf ADDRESS
4000 Birch St Ste 120 lYPEESTABliSHMENT INSPECTED
5038 OuLsourcing f acility
OATE ISSUEO EMPlOYEE($) SIGNATURE
Ademola 0 Daramo la InvestigatorSEE REVERSE 08252014Binh T Nguyen Investigator ~ OF THIS PAGE
FORM FOA 48J (09tl8) PR~IOUS EDITION OOSOI ErE INSPECTIONAL OBSERVATIONS PAGE 6 OF I) PAGES
C There are no sterile goggles worn during production of sterile products
D There is facia l skin exposure during production of sterile products
E Employees can bring cell phones and head phones to listen to media during production of sterile products
For example
a) On 8182014 we observed your Pharmacist ) and Pharmacy technicians - ) during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgOlml PFS syringe lot 8081814) inside the ISO 7 cleanroom and ISO 5 laminar flow hood wearing non-sterile glasses (without goggles) non-sterile face masks and non-sterile hair nets We also observed B had B head phones (worn beneath non-sterile hairnet) connected by wires to a cell phone (stored in plastic bag) placed inside the hood (within 6 inches from the hoods edge) to listen to media
(b) (6)b) On 8 182014 the employees ) had their forehead eyebrows eyelashes and neck region exposed during aseptic processing (compounding and filling) of sterile human drugs (Bevacizumab 25mgO l ml PFS syringe lot 8081814) During the performance of this sterile operation they had their foreheads inside the ISO 5 laminar flow hoods where there was no physical barrier between their exposed skin or the non-sterile face masks and the open 10 ml Bevacizumab glass vials on the LFH work surface
(b) (6)c) On 8 182014 we observed that the employees ) street clothes were protruding from under the gowns worn during the aseptic processing of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 inside the ISO 7 cleanroom and ISO 5 laminar flow hoods
l ( b ) (6 ) d)On 81I 82014 we also observed that the employees ) entered the cleanroom and engaged in the aseptic production of sterile Bevacizumab 25mg01 ml PFS syringe lot 8081814 while wearing shoe covers over their shoes the shoe covers were donned inside a non-classified area of the facility
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DEPARTMENT OF JIEAITII AND HliMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT AOORESS AND PHONE NUMBER
19701 Fairchild Irvlne Cl 9612 (94 9) 608 - 2900 Fax (949) 608-4417 Industry Information www fda govocindustry
OATE(S) OF INSPECTION
0818 2014 - 0825201 4 FE NUMBER
3004600090
NA~UO ANO fTLI OF INDIVIOJAL TOWlltQll REPORTISSVpound0
TO Mr Glen A Olsheim Chief Operating FIRMMMIE
California Pharmacy amp Con~ounding Center CITY STATE ZIP CODE COUNTRY
Newport Beach1 CA 92660- 2258
Officer STREET AODRE$5
4000 Birch St Ste 120 TYPe ESTABLISHMENT INSPEC TEO
5038 Outsourcing Facility
~ middot- - -
DATE ISSUEDEMPLOYEE(S) SKlNATVRE
Ademola 0 Daramola InvestigatorSEE REVERSE 08252014Ri n h T Nguyen Invest igator (5NOF THIS PAGE
FORM fDA 483(0908) PRE10US EDITION OOSOLE IT INSPE(TIONAL OBSERVATIONS PAGJ 7 OF IJ PAGES
OBSERVATION 7
Written records are not made of investigations into unexplained discrepancies
Specifi cally your firm failed to document internal investigation of three cases of product leakage in transit during shipment for steri lity tests For example
1 On 511420 14 one sample of Oxytocin Nasal Spray 360 iuml solution (sterile) lot B051414B leaked during transit to the steril ity testing laboratory
2 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study IND 100860) 120 iuml solution lot AB062614 was found to have leaked out during transit to the sterility testing laboratory
3 On 070112014 one sample of Oxytocin Nasal Spray (Investigational study) 120 iuml solution lot RB062614 was found to have leaked out during transit to the sterility testing laboratory
According to the chief operating officer and quality control specialist your firm conducted an in house investigation to find the root cause of t he leaks from the investigation the firm dcte1mined the root cause and implemented conective action However there is no written documentation of the steps involved in the investigation the conective action and effectiveness checks of the conective action taken
Laboratory System
OBSERVATION 8
Employees are not given train ing in the particular operations they perform as part of their function current good manufacturing practices and written procedures required by current good manufacturing practice regulations
Specifically
A Your firm does not have a written and approved employee train ing procedure to guide your technicians during conduct of sterile aseptic processes including frequency of training There are no employee training logs document ing how and when each employee was trained in aseptic processes
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DATE ISSUEDEMPLOYEE(S) SIGNATURE
Ademola 0 Dararnola InvestigatorSEE REVERSE 08252014Blnh T Nguyen Invesl igator fftJOF THIS PAGE
FOilM FIM 4H3 (0108) PREVlOUS EOilION OnSOLE TE INSPECTIONAL OBSERVATIONS rAGES OF ll PAGES
DEPARTMENT OF U EALTH ANO m MAN SERVI CES lmiddotOOLgt AND DRUG ADMINISTRATION
DISTRICT AD DRESS AND PHONE NUMBER
19701 Fairchild Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 Industry I nformat ion wwwtdagovocindustry
I ltAt1E AIIO Tlrlpound Of INOCVIOIMI TO IMlOtl REPORT ISllUEO
TO Mr Glen A Olsheim Chief 0 eratinq Officer
OATE(S) OF INSPECTtON
08182014 - 08252014 FEINUMBE
3004600090
Fl NME
California Pharmacy amp Com ounding Center CITY STATE ZIP CODE COUNTRY
NewporL Beach CA 92660- 258
S TREET ADDRESS
4000 Birch St Ste 120 TYPE ESTABLISHMENT INSPECTED
5038 Outsourcing Facility
B There is also no trainin erfonn l 00 visual ins ection checks of sterile dru roducts
OBSERVATION 9
Each batch ofdrug product purporting to be sterile is not laborat01y tested to determine conformance to such requirements
Specifically your firm does not conduct sterility testing for Nandrolone Decanoate Oil Injection (b) (4) 200mgml solution (non-sterile to sterile process using non-validated ) a
patient specific product with BUD of 3 days
OBSERVATION 10
Laborat01y controls do not include the establishment of scientifically sound and appropriate test procedures des igned to assure that drug products conform to appropriate standards of identity strength quality and purity
Specifically your firms practice ofvisual inspection is deficient as follows
A Your firms product inspection process is deficient in that you do not perform 100 visual checks against a contrasting background of your steri le liquid formulations prior to release Per the Pharmacist in Charge (PIC) about bull of the finished products are v isually inspected Your firm has not established a written procedure for performing products visual checks
B On 8 192014 during a demonstration of visual check by your pharmacist ) I observed that the e mployee shook the vials when inspecting them for particulate matter and fungal growth
OBSERVATION 11
Results of stability testi ng are not used in determining expiration dates
Specifically your firm fialed to conduct preserative content testing for your sterile fin ished products at the time of release For example
A Thirty three (33) different sterile formulations containing preservative and fourteen (14) different sterile formulations containing released without performing preservative content testing
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DFPARTiIENT OF IIEALTII ANO Ul lMAN SERVICES FOOD AND DRUG A DMINISrRATION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) 608 -4417 Industry Information www fda govocindustr NAME AND ffllE Of INOIVlDVJ1 TO WllOM REPORT ISSUEO
TO Mr Glen A Ol sheim Chief 0 erating Officer
DATE(S) OF INSPECTION
08182014 - 08252014 FEI NVWBER
3004600090
F RIAHMIE S IREET oDORESS
Cal i forn i a Pharmac amp Compounding Center 4000 Birch St Ste 1 20 CTTY STATE ZIP CODE COUNTRY TYIgtE EnAEJUSHMENT INSPECTED
New ort Beach CA 92660-2258 5038 Outsourcing Facilil
DATE ISSUED
Ademo1a o Daramola InvestigatorSEE REVERSE 08252014Binh T Nguyen InvcstigaLormiddot fsrJOF THIS PAGE
fOR~I f01 ~8J (091081 f ltt-VIOUS 1301110N OBSOlfTJ INSIECTIONAL OBSt R VATIONS PAGE 9 OF 11 IAGFS
(b) (4)
Vancomycin Sterile to sterile opthalmic l4mgml lot B718067 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1Omgml lot B721598 Vancomycin Sterile to sterile opthalmic l4mgml lot 8718067 Mometasone Nasal Non-sterile to sterile 600mcg25ml lot 8721084 Voriconazole Sterile to sterile opthalmic 1 Omgml lot 8720846 EDTA opthalmic 2 Non-sterile to sterile lot B720464 DMSOGlutathione Non-sterile to sterile 125 opthalmic lot B713477 Voriconazole Sterile to sterile opthalmic 1 Omgml lot B720406
Sterile to sterile
Sterile to sterile
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DfPiRTMENT OF HEALTH ANIgt HUMAN SERVICES FOOD AND DRUG ADMINISTRAT ION
DISTRICT ADDRESS AND PHONE NUIABeR OATE($) OF INSPECTION
19701 Fairchild 08182014 - 08252014 FEI NUMBERIrvine CA 92612
(949) 608-2900 Fax (949) 608-4417 3004600090 Industry Information wwwfdagovocindustry NAMI ANl JtllEOf INOIVIOUILTO WHOM REPORT ISSUED
TO Mr Glen A Olsheim Chief Operating Officer FIRol NAME
California Pharmacy amp Compo u nding Center CITY STATE liPCODE COVNTRY
New ort Beach CA 92660-2258
STREET AOORESS
4000 Birch St Ste 120 TYPE ESf ABLISHAEN T INSPECTED
5038 Outsourcing Facility
SEE REVERSE OF THIS PAGE
fORM fOA 43J (09108)
EMPLOYEE(S) SIGNATURE
Ademola o Daramola Investigator Binh T Nguyen Investigator 08252014
PREVIOUS EOniOIf ODSotEl f INSPECTIONAL OBSERVATIONS PACE 10 OF IJ PACFS
Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8719847 Voriconazole Sterile to sterile 9days opthalmic 1Omglml lot 8719498 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719607 Voriconazole Sterile to sterile 9 days opthalmic 1Omglml lot 8719498 Vancomycin Sterile to sterile 9 days opthalmic 15mglml lot 8718067(3) 51714 Interferon Alta 2B Non~sterile to sterile 14 days opthalmic lot 8710261 Dexamethasone Non~sterile to sterile 14 days opthalmic 01 lot 80507148
In addition to the eighteen products depicted in the above table fifteen product lots were also (b)(4)compounded using as a preservative
Nadrolone Decanoate lOOmgml inj lot Non~sterile to 8717389 sterile Hydroxyprogesterone caproate m Non~sterile to 180 days castor oil lot B041214A sterile Progesterone In ethyl oleate lot Non~sterile to B041314A sterile
(b) (4)
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DUgtARTMENT OF HEALTH AND ll liiIAN SERVICES 1middot000 ANO ORU(i ADMINISTRATION
OISlAICT ADDRESS AN0 PHON( NUMBER DATE(S) OF INSPECTION
19701 Fairchild Irvine CA 92612 (949) 608-2900 Fax (949) IndusLry Information
608-4417 wwwtdagovocindustry
08182014 fEINUMBER
3004600090
- 08252014
NAME 11110 lTTlE OF INDVIOltIAL TO WUOM REPORTISSUID
TO Mr Glen A Olsheim Chief Operatinq Officer FIRM Nl1E
California Pharmacy amp Compounding Center CITY STATE ZIP COOE COUNTRY
Newport Beach CA 92660-2258
STREET ADORES$
4000 Birch St Ste 120 TYIE ESTABLISHMENT INSPECTEO
5038 Oulsourcing facility
OATEISSUEOEMPLOYEE($) SIGNATURE
Ademola 0 Daramola InvestigatorSEE REVERSE 082S2014Bjnh T Nguyen Investigator ~ OF THIS PAGE
~ORM FDA 48J (09031 PREVIOUS EDITION OBSOI~TE INSPECTIONtL OBSERVATIONS PAGE II Of IJ PAGES
Progesterone in ethyl oleate lot Non-sterile to 90 days B050714A sterile Hydroxyprogesterone caproate m Non-sterile to 180 days castor oil lot B052314R sterile Hydroxyprogesterone caproate in Non-sterile to 180 days castor oi l lot 8071714A sterile Progesterone in ethyl oleate lot Non-sterile to 90 days B071814A sterile Progesterone Cypionate Non-sterile to 3 days
middot lot B717688 sterile Non-sterile to 3 days sterile
PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720839 sterile PhosphatidylcholineDeoxycholic acid Non-sterile to 3 days middot middot 542 lot B720838 sterile Testosterone cypionate 120mg3mgml Non-sterile to 3 days middot middot lot 8717688 steri le Testosterone propionate 200mgml inj Non-steri le to 3 days lot 8720246 steri le Nadrolone Decanoate 200mgml inj lot Non-sterile to 3 days 8720024 sterile
Produ ction S stem
OBSERVATION 12
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include val idation of the sterilization process
Specifically media fi ll simulations are deficient
A They do not simulate the worst case scenario in your sterile process including the retrieval of
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
DEIARTlmiddotI ENT OF IlEALTil ANIgt til lMAN S FItVI CES FOOD AND DRUG AIgtMINIS IRA l iON
DIST IC ADORESS ANO PHONE NUMBER OATE(S)OF INSPE T
19701 Fairchild 08182014 - 08252014 INUMBEIIIrvjne CA 9261
TO Mr Glen A Olsheim Chief Operatin Officer NAME SlRUf ADORISS
California Pharmac amp compoundinq Center 4000 Birch CITV STATE ZIP COllE COUNTRY TVPE ESTABUSgtiNENT
Newport Beach CA 92660-2258 503B Outsourcin FacLltty
OAE ISSUED
Adcmola 0 Daramola InvestigatorSEE REVERSE 08252014BLnh T Nguyen InvestigatorOF THIS PAGE
VOHM ID 433 (09081 PREVIOLI~ EOITIO~OUSOLETE INSIECTIONA L OBSERVATI O~S PAGF 11 OF ll PAGF~
(b) (41sterile rubber stoppers from sterile tote bags opened for in the LFH and the capping process
13 Additionally your media fills do not simulate acceptable hold times including the maximum length of production times
OBSERVATION 13
Procedures for the preparation of master production and control records are not followed
Specifically your firms logged formulation worksheet (LFW) documenting the production steps of Hydroxyprogesterone caproate 250m gml injectable was not fo llowed during the compounding Your tirm s technicians used located inside the ISO 8 ante before transferring it to the ISO 5 laminar flow hood in the ISO 7 clean room for fi lling The LFW states that all procedures shall be performed in a laminar flow hood clean air workstation within a cleanroom utilizing aseptic teclmique
Packa in and Labcl in S stem
OBSERVATION 14
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations
Specifically your finns label procedure SOP 800 Effective Date 07I 18114 titled Standard Operating Procedure Labeling Storage Shipment and Disposal Procedure is deficient in that it fails to address label issuance identification storage handling sampling and reconciliation In actual practice any pharmacist can print out a number of labels for use
OBSERVATION 15
The labels of your outsourcing facilitys drug products do not include infonnation required by section 5038 (a)( IO)(A )and ( B)
Specifically the labels a ffixed to your firms drug products do not include the statements This is a com pounded drug Not for resale and Office Usc Only The labels affixed to the drug products
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
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~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
OErARTMENT(H IIEALTII ANIgt lll liIAN SERVICI~S FOOD ANIgt DRUG ADMINISTRATION
DISTRICT AOORES3 ANO PHONE NVMUER
1 9701 fairchild 08 182014 - 08252014 Irvine CA 92612 (949) 608 - 2900 Fax (949) 608-4417 3004600090 I ndustry Information wwwfda yovocindustry tfVIE MD TITlE Of OIVIOOAl TO gtMlt01 REIOilT t$SVIO
TO Mr Glen A Olshelm Chief Operat ing FIRM IIMIE
California Pharmacy amp Compounding Center CllY STAlE 71PCOOE COON1RY
Newpo rt Beac h CA 92660 - 2258
Officer SlRpoundETtOORESS
4000 Birch St Ste 1 2 0 tPEESlABUSgtttFNTUltSPIClED
gt038 Outsourcing Facili ty
also do not include the following required information name address phone number of your outsourcing faci lity dosage form and strength statement of quantity or volume as appropriate date drug was compounded expiration date and storage and handling instructions Furthermore neither the drug product label nor the container from which the individual units of the drug are removed for dispensing or administration include a list of inactive ingredients identified by established name and the quantity or proportion of each ingredient In addition the container from which the individual units of the drug are removed for dispensing or administration do not contain the following information to facilitate adverse event reporting WW ICiauovmcdwatch and l-800-FDA-l 088 lthttpwwwtdagovmcdwatch and 1-800-FDA-1 088gt
Labels for the following drug products do not contain all of the required information described above
1 Vancomycin Intravit 1 MG0 1 ML Sol 11 BevacizumabDexameth l25MG 1 MGOlML SoL ii i Proparacaine Opth 005 Sol 1v Bevacizumab 125MG005ML Sol v Ceftazidime Intravit 2 25MGO l ML Sol
~
~-==a----=-shySEE REVERSE ~_) L cshyOF THIS PAGE -==-lt (~ --~
PIUiVIOliS ED PAGE 13 Of IJ P-GIS FOR~I IIJA 43l (01JSI I fiON OOSOIf TE 11SPE(TIONAI OBStRVATIO~i
EWUVEE(G) SICUIATURE
Ademola 0 Daramola InvestigatorBinh T Nguyen Investigator ~
- I
OAlE ISSUEO
08252014
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
The observations of objectionable conditions and practices listed on the front of this form are reported
1 Pursuant to Section 704(b) of the Federal Food Drug and Cosmetic Act or
2 To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration
Section 704(b) of the Federal Food Drug and Cosmetic Act (21 USC 374(b)) provides
Upon completion of any such inspection of a factory warehouse consulting laboratory or other establishment and prior to leaving the premises the officer or employee making the inspection shall give to the owner operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgement indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health A copy of such report shall be sent promptly to the Secretary
