DEPARTMENT OF HEALTH AND HUMAN SERVI CES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 10903 New Hampshire Ave,Bldg 51,Rrn 4225 10/30/201 7- 11/3/201 7 Silver Springs, MD 20993 F EJ NUMBER (30 1) 796 - 3334 Fax: (30 1)8 47 - 8738 3010166683 NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED Mihir Dave, Facility & Compliance Head FIRM NAME STREET ADDRESS TRUECARE BIOMEDIX College Road, Dis tri ct Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED Balasinor, Gujarat, 388255India manufactu rer This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding yom· compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, con-ective action in response to an observation, you may dis cu ss t he objection or action v. ,ith t he FDA representative{s) dm-ing the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone nmn ber and address above. DURING AN I NSPECTION OF YOUR FIRM I OBSERVED: LABORATORY CONTROL SYSTEM OBSERVATION 1 Laboratory records are deficient in that th ey do not include a com 12lete record of all data obtained during testing. Electronic records are used, but th ey do not meet reguirements to ensure that th ey are tmstworthy, reliable and generally equivalent to 12a12er records. Specificall y, you ca nnot ensure all data is repo1ted and all data repo1ted is accurate in that: i) not all data obtained and activity occmTing on HPLCs in your QC laborato1y is documented, tracked and recorded. a) The QC In-Charge, overall responsible for all product testing and review of data prior to approval and release, is assigned two roles (system administrator and test manager) for software used in association with HPLC inst mments in the QC laboratory. One or both of these roles have assigned privileges including but not limited to delete projects on HPLC/073 and HPLC/069. HPLC/033 does not have an audit trail function. Operators using HPLC/033 have user rights to delete data temporarily stored on the instrument. Your QC In-Char~e stated HPLC/033, HPLC/069, and HPLC/073 are all used . lb)(4) I. tl>J 4) E lb)(4) ln lb)l4) for product testmg fori and ablets g mg), lbH 4 l T bl t USB' 0 )( 4 ) d r 1141 C 1 usrr )( 4 '. a e s n g, an I apsu es mg. b) Pro ject folder APAP-500-SEP-2017 saved on the C:\ drive in the Data folder within the LabSolutions folder on the standalone workstation used with HPLC/073 last modified September 8, EMPLOYEE(S) SIGNATURE DATE I SSUED SEE REVERSE Cheryl A Clausen, Investigator 11 /3/20 17 OF THIS PAGE ~,_ . A.0au6elt-S X S11.J81~21117232649 FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE I OF 11 PAGES
Transcript
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
10903 New Hampshire Ave,Bldg 51,Rrn 4225 10/30/2017 - 11/3/2017 Silver Springs, MD 20993 FEJNUMBER
(301) 796 - 3334 Fax: (301)847 - 8738 3010166683
NAME AND TITLE OF INOM OUAL TO WHOM REPORT ISSUED
Mihir Dave, Facility & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Distric t Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gujarat, 388255India manufact u rer
This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding yom· compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, con-ective action in response to an observation, you may discuss the objection or action v.,ith the FDA representative{s) dm-ing the inspection or submit this information to FDA at the address above. If you have any questions, please contact FDA at the phone nmnber and address above.
DURING AN INSPECTION OF YOUR FIRM I OBSERVED: LABORATORY CONTROL SYSTEM
OBSERVATION 1 Laboratory records are deficient in that they do not include a com12lete record of all data obtained during testing. Electronic records are used, but they do not meet reguirements to ensure that they are tmstworthy, reliable and generally equivalent to 12a12er records.
Specifically, you cannot ensure all data is repo1ted and all data repo1ted is accurate in that:
i) not all data obtained and activity occmTing on HPLCs in your QC laborato1y is documented, tracked and recorded.
a) The QC In-Charge, overall responsible for all product testing and review of data prior to approval
and release, is assigned two roles (system administrator and test manager) for software used in association with HPLC instmments in the QC laboratory. One or both of these roles have assigned privileges including but not limited to delete projects on HPLC/073 and HPLC/069. HPLC/033 does not have an audit trail function. Operators using HPLC/033 have user rights to delete data temporarily
stored on the instrument. Your QC In-Char~e stated HPLC/033, HPLC/069, and HPLC/073 are all used . lb)(4) I. tl>J 4) E lb)(4)ln lb)l4)
for product testmg for i and ablets g mg), lbH
4l T bl t USB'0)(
4) d r1141 C 1 usrr)(4'. a e s ng, an I apsu es mg.
b) Project folder APAP-500-SEP-2017 saved on the C:\ drive in the Data folder within the LabSolutions folder on the standalone workstation used with HPLC/073 last modified September 8,
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Investigator 11/3/201 7 OF THIS PAGE ~,_
. A.0au6elt-S
X S11.J81~21117232649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE I OF 11 PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facility & Compliance Head F IRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Distric t Mahisagar CITY. STATE. Z IP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gujarat, 388255India manufacturer
2017 at 16:36 does not contain data. Project folder APAP-500-SEP-2017 is not viewable in Project folders drop down list in the LabSolution software used with HPLC/073. The audit trail for HPLC/073
does not show this project folder or any activity involving this project folder on September 8, 2017.
ii) Analysts in your QC Laboratory share the same usemame and password to access the Windows 7
operating system on all standalone workstations used with FT-IR and HPLC instmments. Your FT-IR is used to conduct the specific identity test for active ingredient tl>H(J .USP release. HPLCs are used for assay and dissolution testing for tl>H(> I d (b)(4)
iii) Analysts in the QC laborato1y have the ability to change the date and time setting for the Windows 7 operating system on all standalone workstations.
iv) you do not have an established protocol for naming folders and data files saved on standalone
workstations in the QC laborato1y. Not all project folders saved on standalone workstations are listed in
the project folder list in the software used to control HPLCs.
v) Analysts in your QC laborato1y can change the date and time on both the analytical balance and the
printer for analytical balance QC/BAL/032.
vi) you do not control, track, or docUII1ent the number of copies of Analytical Repo1is (A.R.) issued for each batch nUII1ber of each dmg product. When a second copy of an A.R. is printed there is no
indication on the second printed copy it is a second copy. Your QC In-Charge stated you do not
docUII1ent or track the nUII1ber of A. R.(s) issued for each product batch number.
OBSERVATION 2
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Investigator 11/3/201 7 OF THIS PAGE """>'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 2 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facility & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Distric t Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gujarat, 388255India manufacturer
Written calibration procedures for instrnments, apparatus, gauges, and recording devices are deficient in that they do not include specific directions and schedules.
Specifically, you do not always properly calibrate equipment used in the QC laborato1y in that:
i) you have not calibrated the polystyrene film used to calibrate your FT-IR since January 7, 2014. You d . fi . d . . D r (4) '· d . h f: rt (4) I con uct spec1 1c 1 entity testmg or . ~ SP use m t e manu acture o
andr H4> !Tablets ((b114] mg (bH
4> g) andfbll4> !Tablets USP<bH4
> ~mg by FT-IR.
ii) weights QC/WT/053, used fo f(bH4> 1weight checks on analytical balance QC/BAL/032 in the QC
laborato1y , were calibrated August 31, 2017. The aforementioned weights, used for sample preparation, have scratch and indentation marks. Indentations and scratches can impact the accuracy of weights. Your QC In-charge stated the weights were returned with these scratch and indentation marks after
calibration traceable to a ce1iified standard.
OBSERVATION 3 The accuracy, sensitivity, specifici!Y and reproducibility of test methods have not been established and documented.
Specifically, you have not verified USP <711> under actual conditions of use in that:
i) Your Facility and Compliance Head stated you have not verified test method USP <711> .
ii) USP <711> states if dissolved gases influence dissolution results, dissolved gases should be removed from the buffered dissolution medium prior to testing. Your QC In-Charge stated you removes gases by sonication rather than degassing the buffered dissolution medium under vacuum.
iii) your QC In-Charge stated you do not have data comparing with degassing under vacuum and have not evaluated the impact on fmished product dissolution testing forr ll4> :and
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Investigator 11/3/201 7 OF THIS PAGE """>'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 3 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facility & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Distric t Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gu jarat, 388255India manu factu rer
lb)l4)ln {b)(4) l_ bl t ~ lbjn ) lb)(4) I a es g g ,I f Tablets USP g, and (b)(4) lbH4l I _capsules USP mg.
OBSERVATION 4 The s12ecifications for in-12rocess materials are deficient in that they do not include a descri12tion of the sam12ling 12lan for in-m·ocess materials.
Specifically, your Procedure for Sampling of In-Process, Finished Product, Stability Samples and
Validation Samples QA-025-04 effective March 7, 2017 does not include sufficient details to ensure in-
process samples are representative. Your Production In-Chanre stated samples taken from the~b><4>
lb)(4) lb)(4) . ~b)(4) 1· {b)(4) . . fo11" 1analys1s are not taken from thel when the j
1are m motion and
t lier 1141 lis nmning.
OBSERVATION 5 Reserve sam12les from re12resentative sam12le lots or batches of diug 12roducts selected by acce12table statistical m ocedures are not examined visually at least once a year for evidence of deterioration.
Specifically, you do not document and quantify evidence of deterioration as pali of annual visual examination ofretain samples for diu g productstbH4> \nd "b)(4) 'r ablets {b)(4) LJI1 ) r (4) ir bl t USP lb)(4) •. -r )(4) '· 1:6)14)'
,Capsules USP mg mg g , a e s mg, or
shipped to the U.S.
t
QUALITY SYSTEM
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Investigator 11/3/201 7 OF THIS PAGE Clle<l'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 4 0F II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/2017- 11/3/2017 S i lve r Springs , MD 20993 FEJNUMBER
Mihir Dave , Fac i l ity & Compliance Head F IRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Di s tric t Mahisagar CITY. STATE. Z IP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balas i nor, Gujarat, 388255I ndia manufacturer
OBSERVATION 6 The res12onsibilities and 12rocedures a1212licable to the guali!Y control unit are not in writing and full1 followed.
Specifically, written procedures do not always include sufficient details to ensure consistent implementation and written procedures are not always followed in that:
i) your Procedure for Sampling of fu-Process, Finished Product, Stability SamJ)les and Validation · tb)(4) "b)(4)
Samples QA-025-04 effective March 3, 2017 for and ablets tb)(4) g/2(b) tl>J14) I tb)(4) (b)(4) I tb) (On '<4> mg),I Tablets USP 'mg, and I Capsules USP ~ g
shipped to the U.S. does not have sufficient details to ensure representative samples are taken. The aforementioned procedure does not include specific details describing where to collect in-process samples and how to obtain a representative in-process sample.
ii) your Procedure for Handling of Customer Complaints QA-029-01 effective November 19, 2015 does not specify extending complaint investigations to other products if other products could be impacted.
iii) your Procedure for Vendor Approval/Qualification QA-034-02 effective November 20, 2015 does
not specify:
a) verification of the reliability of the manufacturer's CoA (Ce1tificate of Analysis) or a frequency for re-verification of the reliability of the manufacturer's CoA.
b) critical vendors must be audited or the frequency for conducting on-site vendor audits.
iv) your Procedure for Out of Specification (OOS) QC-037-01 effective November 26, 2015 appears to allow resampling and retesting after a second analyst obtains an OOS retest result(s) and exclusion of
OOS results based on trend analysis.
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, I nvestigat o r 11/3/201 7 OF THIS PAGE """>'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 5 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER
1 0903 New Hampshire Ave,Bldg 51,Rrn 4225 Silver Springs, MD 20993 (301) 796 - 3334 Fax: (301) 847- 8738
NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
Mihir Dave, Facility & Compliance Head F IRM NAME
OATE(S) OF INSPECTION
1 0/30/2017- 11/3/2017 FEJNUMBER
3010166683
STREET ADDRESS
TRUECARE BIOMEDIX College Road, District Mahisagar CITY. STATE. Z IP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasino r, Gujarat, 388255India manufacturer
v) your Procedure for Conducting Stability Study QC-042-00 effective December 19, 2016 does not specify:
a) initiation of a Field Aleii Report (FAR) within 3 working days after obtaining an OOS result for
stability study test samples.
b) a time range for pulling stability study samples from the stability study chamber for testing.
vi) your Cleaning Procedure for Changeover Canied Out in Manufacturing and Packaging Area PRD-040-01 effective Febrnaiy 5, 2016 is not consistently followed:
a) section 6.2.3 specifies to remov~ all residue. On November 1, 2017 I observed what appeared to be . . <bH4> I lbH4> , f(bl14>
diug product residue m the capsulel· f OOm used fori .Capsules USP mg on the covers for AHU/017 /RR02 and AHU/017 /RR03. The room status was labeled as clean November 1, 2017 and was last used October 31, 2017. Your Facility and Compliance Head confnm ed diug product residue remained on the aforementioned covers.
b) does not specify if equipment should be cleaned before use after maintenance activities.
vii) your Procedure for Operation, Calibration and Cleaning of Conductivity Meter QC-249-00 effective . . . h [(61141 rod d . I . h August 21 , 2] 17 sect10n 6.3.1 states to nnse wit an section 6.7.1 states to c ean wit
{b)(4) lb)(4) -i(b){-4) Your QC In-Chai·ge statedi rom your
1 ystem
-is used for cleaning and calibration of the conductivity meter. ----------
viii) your Procedure for Handling of Returned/Rejected Goods WH-015-00 effective October 31, 2017
does not:
a) require customers to provide infoimation regarding storage and handling of the returned material.
SEE REVERSE OF THIS PAGE
FORM FDA 483 (09/08)
EMPLOYEE(S) SIGNATURE
Cheryl A Clausen, Investigato r
X
PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS
DATE ISSUED
11/3/201 7
PAGE 6 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facilit y & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Dist rict Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gujarat , 388255India manufact urer
b) specify what to evaluate or how to evaluate material returned with damage to primaiy packaging before allowing reuse or rece1i ification of the returned product.
c) specify what to evaluate or how to evaluate material not meeting customer specifications before
allowing reuse or receliification of the returned product.
OBSERVATION 7 Written production and process control procedures ai·e not documented at the time of perfo1mance.
Specifically, your Procedure for Issuance and Control of Batch Manufacturing Records QA-009-01
effective October 4, 2017 for lb)(4) andtbll4J ,, f(b)(4)ln !bJ
lbl (4)~ ;capsules USP g shipped to the U.S. specifies an additional page can be issued in case of wrong entry on page. Your Facility and
Compliance Head stated the page with the wrong entiy is removed and stored in QA. This procedure
does not include instructions for co1Tectly co1Tecting wrong enti·ies by drawing a single line through the
inco1Tect info1mation, recording the correct information, recording the reason for the error, and initialing
and dating the correction rather than replacing the page.
FACILITIES AND EQUIPMENT SYSTEM
OBSERVATION 8 Backup data is not assured as exact, complete and secure from alteration, erasure or loss through keeping hard copy or alternate systems.
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Invest igat or 11/3/201 7 OF THIS PAGE """>'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 7 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facilit y & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Dist rict Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gu jarat , 388255India manu fact u rer
Specifically, you do not have a written procedure(s) for data back-up and verification of restored data.
OBSERVATION 9 Egui12ment and utensils are not maintained at a1212ro12riate intervals to 12revent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drng product.
Specifically, you do not always properly maintain equipment in that:
i) you do not have a written procedure(s) describing how to clean the water lines for the humidifiers on
your stability study chambers and the frequency to clean the water lines for the humidifiers on your
stability study chambers. Cleaning the water lines associated with the humidifiers on your stability
study chambers is not part of a preventive maintenance plan or schedule.
ii) water drain lines from the humidifiers on your stability study chambers are not affixed to the drain
pipe in a manner to prevent water leaking in, around, and under your stability study chambers .
. .. ) lb)l4) i 1 . d. . f(b)(4) ! nk d . t: I 111 a eve m 1cator m Y.,ur storage ta struts an stops generation o (b)14) -rm1 (b)(4) I !bl (4) I from your ; ystem. leaks from th~o1i with the LJievel indicator.
(b)(4) lb)l4) I. It also appears there arel Jeaks in the pipe fittings below the I ,storage tank leading to
tb)(4) ! . tb)(4J t . thel storage tank. Leaks m youri ~ tern are potential sources for
. . b)(4J ,: bH4> . ti>m J tbH4J ~n contammat10n. ,is used to prepare tablet(' olut10n and for thel
capsules.
. ) (b)(4 ) IV I ~enerated from an rn4l iSystem QC/!bH41
064 in your QC laborato1y is used to prepare the buffer solution medium for dissolution testing and working standm·ds
used for dissolution testing for~bH4J ndr 14J Fablets "bH4l mg ~ g),
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clau sen, Invest igat or 11/3/201 7 OF THIS PAGE """>'Aaa..... = s By QIIMY:_IA. Ctausen-S
X eSIJ'le(l 11-0~20f72'32649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 8 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER
10903 New Hampshire Ave,Bldg 51,Rrn 4225 Silver Springs, MD 20993 (301) 796 - 3334 Fax : (301) 847- 8738
NAME AND TITLE OF INOMOUAL TO WHOM REPORT ISSUED
Mihir Dave, Facilit y & Compliance Head FIRM NAME
OATE(S) OF INSPECTION
10/30/2017 - 11/3/2017 FEJNUMBER
3010166683
STREET ADDRESS
TRUECARE BIOMEDIX College Road, Dist rict Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gujarat , 388255India manufact u rer
OBSERVATION 10 Routine inspection and checking of automatic, mechanical and electronic equipment is not perfo1med according to a written program designed to assure proper perfo1mance.
Specifically, operators do not record readings from measurement devices used to control yourtbH4>
lb)(4) . system m that: ---
") d C • _.;<b)(4) f-C . d 1 your Proce ure 1or Operation 011 ... ________ ... system ENG-010-02 e 1echve Januaiy 2, 2017 oes . d . f d d d . d lbH4> not reqmre ocumentat10n o rea -outs an measurement ev1ces use to generate ... _____ ... or
provide specifications for measurement devices used to generatett>1141
. ") "fi . d h . f C d . d "b)(4
) 11 spec1 1cahons are not poste at t e pomt o use 1or measurement ev1ces use to generate lb)(4)
PRODUCTION SYSTEM
OBSERVATION 11 The batch production and conh'ol records ai·e deficient in that they do not include specimen of labeling.
SEE REVERSE OF THIS PAGE
FORM FDA 483 (09/08)
EMPLOYEE(S) SIGNATURE
Cheryl A Clausen, Invest igat or
X
PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS
DATE ISSUED
11/3/201 7
PAGE 9 OF II PAGES
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION
1 0903 New Hampshire Ave,Bldg 51 ,Rrn 4225 1 0/30/201 7 - 11/3/201 7 Silver Springs, MD 20993 FEJNUMBER
Mihir Dave, Facilit y & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Dist rict Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gu jarat , 388255India manu fact u rer
Specifically, labels are not directly affixed to the Batch Manufacturing Record (BMR) for lbJ<4J • d tt>H4> jr bl (fH4>J tbJ<4~ ) tt>H4> II' bl USPtbll4> an a ets mg mg ,i a ets
(b)(4) ~b)(4) . mg, andl ,Capsules USP mg shipped to the U.S. Labels are not affixed to the batch record in a manner designed to identify removal and replacement in that dispensing labels and
finished product labels are placed in a re-sealable plastic bag stapled to the back of a batch record page.
OBSERVATION 12 The batch Qroduction and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, processing and packing.
Mihir Dave, Facility & Compliance Head FIRM NAME STREET ADDRESS
TRUECARE BIOMEDIX College Road, Distric t Mahisagar CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABLISHMENT INSPECTED
Balasinor, Gu jarat, 388255India manu factu rer
') th BMR £ r<4> :Capsules USP~~ mg does not include recording start and end v 1 . e or
. . ) 4 ) . t6H4l times dunng thej < :preparat10n or the1
OBSERVATION 13 Batch 12roduction and control records do not include dates of each sigmficant ste12 in the manufacture of the batch for each batch of diug 12roduct 12roduced.
. t6H4l tl>)(4) . Specifically, the BMR for ~ _capsules USR mg does not mclude the date for tl>)(4) . I taii time and en trme.
EMPLOYEE(S) SIGNATURE DATE ISSUED
SEE REVERSE Cheryl A Clausen, Investigator 11/3/201 7 OF THIS PAGE
""">'Aaa..... = X s By QIIMY:_IA. Ctausen-S e~ 11-0~2017232649
FORM FDA 483 (09/08) PREVIOUS EDmON OBSOlEJE INSPECTIONAL OBSERVATIONS PAGE 11 OF 11 PAGES
