~i. , n~nlt~o~rT------SE-E----~E~M~RL~~O,~~E~E~~S~IG~N~A~T~U~R~E------------------~E~M~P~LO;::;Y~E~E7.(S~)~N~A~M~E~A~N-;:;D~T~IT~LcEI.(Ai,i, I ~~p~e.-)------llro~A~TcE~1 2~:S~U~EnD______

REVERSE ~ OF THIS ( r / Joshua P. Wireman, lnvestigatqr 0&/3\/20 16 PAGE I .j .;:(JL4 ~ ' I - ,

I ! ·--~~~~~~~~ ~~~~~~~~~~-----------+.~~~~~~~~~~~.~ ~--·~~~~~=~~ fORM FDA 483 ~/OB) j PREVIOUS EDITION OBSOLETE INSPECTIONAl OBSERVATlPN S Page ·1 o f 3

~D:;;I;;:ST:;:;:R;;;IC;;:T;:-:O~F;;F;;IC::;:~EFA;;-;D:;;:D;-;;R·';;::Ec;S~S-;:A;:;-N;:;-D-;:;P;:;HO;::;-N;:;;E::-;:;-NU;-;;M;:;;B;::;E::-;:R::-------------------. FLA-DO : j 555 Winderly !Plac~, Suite 200 ! Maitland, FL S275tr . (407) 475-47(0 :

Industry lnforrpatio~: www.fda.gov/oc/industry

..---~i -----------DA, TE(S) OF INSPECTIO" -----·------·

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~/22-26 , 29, 3 1/20 ; 6 rF:-:s+-1 1 -N-u~-r.-BE_R_ _________

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3!005630265i -~NA~M~E~AN~D~I ITTL~E#,O~F~IWN~D~IVMID"U~A"LTT~O~W~HJrOuM~R~E~PvO~R~T~IS~IS~S~U~ED~-------------J_+l -------------------- -

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TO: Christop :er tvf. Schulte, Owner

FIRM NAME

Pensacola Ap ,thec~ry, Inc . DBA Everwell Specialty Phannacy

STREET ADDRESS

6506 N . Davis Highway j

CITY, STATE ANDI:ziP Cs>DE

. Pensacola, FL 'P 25~4 TYPE OF ESTABLI SHMENT IN f "'CTED

Producer of Sterile and fion-sterile Drug P:.-oducis i ~ : i I

!THIS DOCUMENlil ..·i . o~ YOU~ FACILiT~'. THE\' !'.RE P~SPECT ;LIST? OBSERVATIONS MADE BY THE FDA REPRESENTATIVE($) DURING THE JNSPECTIOI~ ONAL : OBSERVATIONS : . ND ifO NOT REPRESENT A FINAL AGENCY DETERMINATION REGARDING YOUR COMPLIANC E. IF ~'OU HAVE At•' OE:JECTION F1::GAF DillS Al'l . OBSERVATION . R H~VE IMPLEMENTED. OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE fO Alii OBSERVAW:m. ·y .::J ·_ ~· l A" DISC ', S: ; TH::" OBJECTION OR j.CTIOI)IIMTH THE FDA REPRESENTATIVE($) DURING THE INSPECTION OR SUBMIT THIS IN FbRIIIi ATimJ TO FD. ~ .;,T T;-:E ADDF~ESS .I' BO ll ( . IF YOU HAVE ANY UESTiONS, PLEASE CONTACT FDA AT THE PHONE NUMBER AND ADDRESS ABOVE. j

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DURING AN INSP 'cTION oF YOUR FIRM (I ) (WE) OBSERVED : I I i

I

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!: i . Sterile Drug :Protluct10n

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ION 1OBSERVA '

:~:~:~~~~e~nne~ gowning apparel improperly, in a way that may have caused!the gowning appare! ro beco ·n"

Specifically ~; the i gowns wom during aseptic production at'e stored on a shelf neXt to the sink tn the anteroon··

where they l ·an be splashed with water during handwashing. ;

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OBSERYA ~~0~ 2 i I !

Equipment, ~at~rials , and/or supplies are not disinfected prior to entering the a!s eptic processing areas.

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Specifically :Ge~eral Aseptic Technique SOP 5.2.1 states that work surfaces o~ th e aseptic pro~uct i on area ~:.1< 1!l b1 cleaned prio to use . While observing the production ofMethylcobalamin Lot 082.420 16@U; tt was noted tnat the

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.inside surfa e on the IS05 unit was not sanitized prior to productiOn. i l :

OBSERVAfiON 4

There are J~• r;tten procedures for p~oduction and process controls designed ..__w _ _ t ,.,, assure that the dn.::g products h<1:v'~the •dent1ty1:strength, quahty, and punty they purp01t or are represented to pos£ess.

f ' i Speciticallj · _. mif_ ing instructions do not i~clude ~uration of mixing to assure th.e _re p li catic~n of the process . For example, t~e lo~ged f01mula worksheet mstructtons for T4-T3 (Dye-Free Veg'g H: c:ap) 8) ~v'!CG .. 15 l\IJCG1Capsule Lo .:08 ~820 16@10 state to mix all powders with agitation in the Turbi1la however the rnixing ·time is not included in he instructions

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~------+-_;:----------------------u .----ztc--•-..UB:-L.~a:J~I~:cJ;.;~..II•ut.. ll:ll ·.:' c .liiL.:£m.::JILI~~~::::.:;nr. rc .,li DEPARTMENT OF HEALTH AND HUI\IIAN SERVICES l lj

I FOOD AND DRUG ADMINISTRATION ; - -~ 0\.\TE(S ) OF INSPECTION !

DISTRICT OFFIC ADDRESS AND PHONE NUMBER [ 1

FLA-DO i &/22-26, 29, 31/2016 I 555 Winder! Plade, Suite 200 i' IMaitland, FL 327 ~ 1 FriNUMBER 1

(407) 475-47DO i $OC5630265 l ~~ln~d~u~st~ry~ln~fu~r£~~a~ti~o~ / / ~ -------------------------------~ ~:;~~-w~'~v;.r;da;.g~o~v;o;c;i;n;du;s~u~~~~~--------------------------~ i

NAME AND TITL .! OF I~DIVIDUAL TO WHOM REPORT IS ISSUED \ l TO: Christot her *· Schulte, OwnerI~F~IR~M-N~A:M~E::~~j~~~~~~---------------------.~ST~R~E~E~T~A~D~ . ·---·· !~ DR~E~S~S------~---------------------------

Pensacola Ap~the~ary, Inc. DBAEverwell Specialty Phannacy 6506 N. Davis Highway\ I CITY , STATE ANC:ZIP q oDE TYPE OF ES i ABLISHMENT IN$P ECTED

Pensacola. FL 32504 Producer of Sterile and lllon-sterile Drug :::- roducts I --------------

SEE REVERSE OF THIS

PAGE

1=0RM FDA 483 ·9/08)\ PREVIOUS EDITION OBSOLETE

EMPLOYEE(S) NAME AND TITLE (.frim or Type) IDATE ISSU ED

I I

Joshua P. Wireman, lnvestigate•r i 0&/31 /2016 I

.---~-fr~ -..l.--------------------~_,~-~:--~ .. ....uu.-L-.... ~--J;:Sl. [;-J; l!lla:n('.'tla:::!: !IU1~ll!ll.'n;a::l...11lll-ll: .. :.:Uill <l ~' ·~ . I DEPARTMENT OF HEALTH AND HUI\!iAN SERVICES I

t,l . FOOD AND DRUG ADMINISTRATION :

1----::-:::=:-±i --:-::-:c'!:::-=-:::-:-:-::::--::7:"::-:-:::-===--------------ct:;:;:~~~~mi---------- -DISTRICT OFFIC ADDRESS AND PHONE NUMBER D~TE(S) OF INSPECTI O N

0 :i i FLA-D 1 i 81n-26, 29, 31 /2u t6 I 555 Winder! ,! Plade, Suite 200

Maitland, FL '0275, 1 (407) 475-47PO \

~~ -------------------------------FE! NUMBER

Industry lnfortnatioh: www.fda.gov/oc/industry NAME AND TITLE ,: OF I~DIVIDUAL TO WHOM REPORT IS ISSUED

I i 3005630265

TO: Christo~~er ¥· Schulte, Owner 1 ~--:::-:c~~=----f----!--------------------------------~-===-=:=-:-==-==--------j-------------------------------

FIRM NAME ! STREET ADDRESS

Pensacola Appthe9ary, Inc. DBA Everwell Specialty Phannacy

: CITY, STATE AN~( ZIP 9 0DE

1 Pensacola, Flp2504

l 6506 N. Davis Highway:

TYPE OF ESTABLISHMENT INSPE::TED

Producer of Sterile and :~on-sterile Drug Pro:l uci s

OBSERVAbo~ ): i

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Written pro :,edures are not established for the cleaning and maintenance of eqyipment, includi ng utensils., used in the manu fa< fure ( processing, packing or holding of a drug product ;

~ ; ! i Specifically '· the! Cleaning And Maintenance of the Non-Sterile Compounding _fl..r,:a SOP 4.1 5 1 ha s not been validated to 'ass~re removal of residual product and sanitizing agents and preveh t crossover betwee:1 batche~.

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SEE REVERSE OF THIS

PAGE

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i EMf'1LOYEE(S) SIGNATURE EMPLOYEE(S) NAME AND TITLE (P[i'lf or Typ.;)

'"""'P w;<emm'"""'''i

DA TE ISSUED

0 &/31/2016 ~ ~~ ~ ":!=~~~~+.~+-=~~==~~~~-----~~~~~.,_.,~~~ .... ~~~ ... ~ ... ---_.......o r 'ill•. ~~--=-:J:IU.I~-~~1::;:; J

FORM FDA 483 ( /08) I PREVIOUS EDITION OBSOLETE INSPECTIONAl OBSERVATIONS Pag 2 3 of 3 '