------· iDJ;Ai~TiAN;uu'~-~~------sE~i~v-~:c~'is~--~-~~~·------·-~~--~~ r FOOD AND DRUO ADMINISTRA'flON ~040 NorthPCentral Expressway, Suite 300 h~~8~~1~0~j~2~0~1~5~-~8~/~2~1~/2~0~1~5~*------:~ Dallas , TX 75204 ; 0~7o31801 i 1 (214 ) 253-5200 Fax: (214)253-5314 ~ Eddie W. Gl over , CEO I Co- Owner

1270 Den' s Lane

Outsourcing Facility

I Titis document lists observations made by the FDA representative(s) during the inspection ofyour fucility. They are inspectional observations, and do not represent a fmal Agency determination regarding your compliance. Ifyou have an objection regarding~~ observation. or have implemented, or plan to implement, corrective action in response to an observation, you may discuss tl.tc objection ()f action with the FDA representative(s) during the inspection or submit this infonnation w FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.

DURING Ail~ INSPECTIOO OF YOUR AR!¥'1 WE OBSERVED: OBSERVA'IION 1 Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equjpment to produr.e aseptic conditions.

Specifically,

A. Your firm's failed to use sporicidal disinfectants in responce to any environmental monitoring findings of spore-fonning organisms When the past 6 months of cleaning logs were reviewed, ao dl)cumentation of use of a sporicidal agent could be demonstrated prior to March of2015.

5 of 11 initial sterility failmes from 2014 to present have occurred due to the presence of spore forming organisms. A comprehensive investigation was not performed. These initial sterility failures are summarized below: " Testosterone 37.5mg Pellet produced on 11106/2014 (Lot Number: 20140611@8) tested positive for Bacillus infantis I.' -:./..f..·.,'?-/·:.\ ~ Methylpred I Lido 40mg/l%/ml produced on:.00/13/2014 (Lot Number: 20141305@3) tested positive for Bacillus thuringiensis • Guaifenesin 5% produced on 04/25/2014 (Lot Number: 04252014@14) tested positive for Bacillus simplex ~ Ketoprofen 100/o produced on 03/24/2014 (Lot Number: 03242014@3) tested positive for t:> ·, , Bacillus circulans '"~ ·· · ~-n~ • Stanozolol 50mg/ml produced on 02/1412014 (Lot Number: 02112014@41) tested t>Qsitive for Bacillus cereus

3Ec REVERSE :-:=~G~~amed, Inve:stigator vf£>;1£.._ 8/21/2015 OF THIS PAGE Lloyd D Payne, I nvestigator ;--;,.___'X_.J.. ___ --i i -·--+L~D~... "-==-~--o:::s:.... ---~ l~!l!!!!.!.=.~!~.ot·- -~~~~;~~~.. 03SE!,V..J!i~ - -!=~-!!.~GilS I ~------·----~"~~~DEPARTMEN-~-~T OF~ HE~--ALTH AN----D HUMAN SERVICES------~~j FOOD AND DRUG ADMINISTRATION Dlll'ffiiCT Ai5ilM5li AND PHON! NOI\j!ER OATC(Sl 01' NIPECTIOH I 4040 North Central Expressway, Suite 300 8/10/2015-8/21/2015* ~ Dallas, TX 75204 FBNI.IMIER (214}253-5200 Fax: (214)253- 5314 3006031801

NAME NIP Tm.E a' JII)IVIOIJAI. Ttl 'MIOM""""""'," ~ f Eddie W. Glover , CEO I Co-OWner FIRM NAMe STREET ADORESS US Compounding Inc. 1270 Oon's Lane OilY, STATE. ZP COOE. COUNTRY lYPE INSP!iCTED I Conway, AR 72032 Outsourcing Facil ity

B. Your firm had visible white powder residue on the ISO 5 Cleanroom Hood 1 and on the adjacent ISO 7 Cleanroom floor duric.g the production of Rocuronium (Lot Number: 20151108@35). When the issue was addressed with your firm, it was suggested that the white residue may be Methylprednisolone from the previous operation. Your firm failed to clean and disinfect surfaces that are visibly soiled. This surface remained visibly soiled during the manufacture of drug product.

C. You move quantities of various production supplies used for aseptic manipulation into the ISO 7 Cleanroom where the ISO 5 KbH4) J is located without sanitizing the outside packaging before they are placed into the ISO 7 Cleanroom potentially increasing the risk of contamination of the control environment.

OBSE.ltVATION 2 Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Specifically,

A. Between 10/1114 and 8/10/15, contact and viable air monitoring exceeded action limits without dccwnentation of a complete investigation, implementatio~ and reassessment in response to excursions above action limits for environmental monitoring of contact surfaces and viable air in the aseptic processing areas. Monitoring included 33 instances actionable contamination ranging up to 49 CFU contact plate inside the ISO 5 KbT(4) j, 271 CFU contact plate in the KoH4) J housed in the I30 8 Glass Storage and Prep and 63 CFU for viable air.

B. Between 10/1/14 and 8110/15, personnel monitoring exceeded action limits during the aseptic processing of sterile products to include 22 instances ranging up to 64 CFU for Gloves and 52 CFU for Personnel Clothing and Garb. You failed to investigate and take appropriate actions after counts for microbial contamination exceeded action limits.

El.ll't.O"t'l!E SIGNI\1\JIUS DATI! ISSI.t:D SEE REVERSE Massoud Motarned, Investigator 8/21/2015 Or THIS PAGE Lloyd D Payne, Investigator

• ~~ --- J I FORM J11)A 483 (t!I/Oa) PJ!E'IIOTIS TlDfl10J< OIISOUlT1! !.!---~ .., ,"~.....,... •=mr••r•..-.t,_.• r------~·------··- ·--n&PA;t;t~o~uiir~uu.MAN8EiV1~--~------~-, FOOD AND DRUO ADM1NISTRATION ll.'Te(S) 4040 North Central Expressway, Suite 300 8/10/2015-8/21/2015* Dallas, TX 75204 El 3006031801 (214)253-5~00 Fax: (214)253- 5314

Co-OWner 8TR ADDRESS

C. Your firm failed to establish alert/action limits for microbial contamination counts on Gloves in ISO 7 areas and alert/action limits on Personnel Clothing & Garb associated with ISO · 5 b 4 where aseptic processing of sterile products is performed.

OBSERVATION 3 Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

Specifically,

A. You failed to consistently review and investigate alerts when the pressure differentials dropped below the minimum set points of H4> W.C. You reported the alarms for the minimum air pressure differential set points were eliminated during a correction made in June 2015, rendering the alarms non-functional.

The current Controlled Environment Performance Test and Certification Report performed on 8/3-4/2015 found that three of the b)(4) air pressure differential gauges were not functioning properly or were in need of calibration including the gauges between the ISO 7 Cleanrooms b) (4 14 and ISO 7 Anteroom 114 and the ISO 8 Chemical Storage and the Unclassified Hall.

B. During aseptic processing of Rocuronium (Lot Number: 20151108@35), it was observed that your finn opened and closed the door between the ISO 7 Anteroo~and ISO 7 Cleanroom:J eight times in one minute. Later. we requested pressure readings between the anteroOm and cleanroom for that corresponding time. Fro:n 2:53 - 2:5S PM tiu~ pressure differentia!, as me2sured by y~ar firm ciumg2d from positive to neg2tive pressure (b) {4} to ...(}.0176). The set point for the positive pressure diffe~n&II was b) (4 Vi .C. Your firm fail~d to ~cknowledge and i:uvestigat ;~ th:e lack of positive press~ res.

EMPI.OVI!I!(S) SIGNATURE SEE REVERSE Massoud Motamed, Investigator 8/21/2015 OF THIS PAGE Lloyd D Payne, Investigator

i . JO.RMJOA~~-...... -= VIOUSIWI~-•t:re------~SPES£~~2~.!!!!!2!!.------P.,..A~.!I!!,~ES -.w~~'-*"~-.::~...~_..=-.s.w~...... -r.tt •--.~..-~,_.:.: ....., DEPAIIUMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMJNISTRATZON Q ...,.. , """ """"""'8 AND PHOIE MJNIIEJl ... 10.-10 North Central Expressway, Suite 300 8/10/2015-8/21/2015* Dallas, TX 75204 FEII'IUI

NAME AND llil.E OF INDIVIOUAL TO V\IHOM fiiiliCiRf 1-..eo i I~die W. Glover , CEO I Co-Owner i i US Compounding Inc. Outsourcing Facility

C. The Controlled Environment Performance Test and Certification Report #90348AE6 dated ><4 t> 4 and #90348AF4 dared t> (4) did not include the dynamic conditions as employed by your finn which includes up t b 4 )people in each of the ISO 7 cleanrooms at any given time and the use of b 4 in the ISO 7 room.

D. You failed to make required corrections to the Facility Engineering Controls as noted in the Air f 4 Safe report (Controlled Environment Performance Test RD.d Certification Report) dated bH I t> 4 in a timely manner and continued to aseptically produce sterile prodm..1:s. The final .. recommendations for conections in the report included making the appropriate adjustments to 1~ the HVAC system, which may include (b} 4 or b 4} to achieve the desired 1 pressure differentials throughout the controlled areas and the calibration or replacement of air presswe gauges that monitor the room pressure between Cleanroom ,.. and Ante Roo ><4 You reported the air pressure monitor between Cleanroom ' ' and Ante Room 114 was replaced in February 2015 but could provide no evidence of such replacement You attempted to make corrections to the air flow and air volume in May 2015 and the again in June 2015. The controlled environment performance test and certifications were not performed after each correction to the HVAC system and air pressm-e monitoring. Your firm continued to produce under these environmental conditions.

In addition, Controlled Environment Performance Test and Certification Report dated (b i!-o!o~~..J iilcluded the same deficiencies to the Facility Engineering Controls including making the Bppropriate adjustments to the HVAC system which may include (b 4 or b 4 t> (4} to achieve the desired pressure differentials throughout the controlled areas and the calibration or replacement of ai; pressure gauges that monitor the room pressure between Cleanrooms !li and and the Ante Room Storage Room and Ante Room , Storage 114 Room iJl4l and Storage Room and Chemical Storage and the unclassified hall. As a result you failed to consistently provide a controlled environment during the production of all aseptically filled human and veterinary products between th b) (4 controlled environment performance tests and certifications.

EIIPI.OYEE(8) SIGHAl\JIIE DATE ISSUB> SEE REVERSE Massoud Motamed , I nvestigator 8/21/2015 OF THIS PAGE Lloyd D Payne, Inves t igator

~ FORti Fl>A ..u (09101) PJU!VIOIJS I'!DITlOH 011S0iE11: INSPECflONAL OBSERVATIONS PAOI! 4 Ot' II ~.!.I k OIIU,..._...... ,..~ ft#f/!~...... _~...,. @UIIIIA.!:~ e D NU i 4040 North Central E.~qJressway, Suite 300 Dal las, TX 75204 (214)253-5200 Fax: (214)253-5314

NAMI! Eddie W. Glover , CEO I Co-Owner

1270 Don's Lane

Out sourcing Facil ity

Furthermore, yow- firm produced product from [t))" 4 Yl to ~bTI41 l on 08/1112015. During this time, yow- firm measured pressure differentials between Anteroom and Cleanroom . During this time, a number of negative pressme differentials were measured and are listed below:

DATE TIME ALARM ALARM PRESSURE ROOM STAMP ACTIVE LOW UNITT ON LCD TYPE false (b)(4 ~0.017594557 Positive false w0,017594557 Positive (b) (4) false -0.017594557 Positive false -0.006621005 Positive false -0.006713362 Positive I false ~0.006713362 Positive false -0.002258667 Positive false -0.006621005 Po~itive false -0.006621005 Positive false -0.006621005 Positive false -0.017594557 Positive false -0.017594557 Positive false -0.017594557 Positive false -0.005605309 Positive false -0.012487253 Positive false -0.012487253 Positive false -0.012903121 Positive false -0.017109128 Positive false -0.017109128 Positive fulse -0.016184563 Positive false -0.016184563 Positive false -0.009553697 Positive

EUPI..O'IE£(8) a~QNATL111; _... r.·· DATE IStlt.EO ·~~ · ·· #:;t SEE REVERSE Massouct Motamed, Investigator ~ ~ i,.,.. \ 8/21/2015 OF TH!S PAGE Lloyd D Payne, Investigator ' ...£ /i '.. >I( ..(7 • - ~ 6 ·---·-....--- -;'E~OiuEAiTH1"'ND'H'U'MA'NSERVias------,~- l r FOOD AND DRUG ADMINJ'STRATION - 1040 Nor t h Cwntral E:'>.:prcssNay, 3uite 300 8/10/2015-8/21/2015* J Dallas, TX 75204 ;~~~~3 1 SOl j ~ (214)253- 5200 Fax : {214)253-5314 1 ~. ~- ~~~~------~------r ; Eddie W. Glov er , CEO I Co- Own er f'1IW NA!IE I• US Compoundl.ng Inc. 1270 Don' s Lane 1OITY . Sl"<\le.lJP cooo.COUI'l!RY lYPE ElJT<\IIUStfl'\eHT ·~ECTe> 5 Conway, AR 72032 Outsourcing Facil ity 1 ------~------! 1 l=:mn::4:1:::::::1 =1==f:=~=e======~>:~:~ ===l=~o=.oo==95=5=36=9=7 =l=P=o=~=tiv=e=:

OBSERVATION 4 ProceG.ures designed to p1event microbiological contamination of drug products purporting to be sterile are not established .

Specifically,

A. Your firm does not perform media fills that simulate production or most challenging conditions. During production, t> 4 is t> 4 . During this process, the vials to be lyophilized, lo!..b~4--!..______~~.!----J b {4 No media fills simulating this process is being conducted. Additionally, your media fills are not conducted to simulate the door opening and dosing times in a single minute as observed between 2:30 and 2:55 PM on 08/11/2015. Instead, your media fills are conducted b 4 .

Furthermore, yQur firm did not begin to implement the use of media fills until 09/24/2014. Additionally, your firm does not qualify operators' via media fills prior to conducting aseptic processes. As of 09/08/2014 the firm hired a new operator {t>J (6 • This operator was qualified for aseptic filling on 03/24/2015 and filled FENTANYL PF 50 Ml (Lot Number: 20152403@28) on that same day. However, until 04/13/2015 >(6 was not qualified by a media fill.

!3. Your firm utilizes a {b 4 to produce: HCG/1312 FOP S,OOOU/600mcg/1ml, HCG/812 FOP 10,000U/1,200mcg/2ml, Dapiprazole 0.5% Opthafmic, Slncalide 3mcg, Sincallde 5mcg, Oeslorelin l.Smg/ml for SDV, Deslorelin & HCG 1.5mg/2000U/ml for SDV, Deslorelin 3mg/ml for MDV, and Deslorelin & HCG 3mg/4000U/ml for MDV. We observed the following for your firm' {5) {4) t> 4 :

EMPLOYEE~ SIGW.T\JRE SEE REVERSE Massoud Motamed , Investiga t o r 8/21/2015 or- TNIS ?AGE Lloy d D Pa yne , Inves tigator r~------··-·•;.A.fi.MENTOFHEALTii'AND HUMANSERVIC;.s--'"___ ..,___ _._ ,..,.,.,. __ ...... _,... ti FOOD AND DRUG ADMINISTRATION DISTRJCT Doll 0 4040 North Central E~;pressway , Suite 300 8/10/2015- 8/21/2015* Dallas, TX 75204 fEINUMeCR (214)253-5200 Fax: (214)253- 5314 3006031801

REPORT IS8UED

•~-~STREET crTY. trrAY£_z,p, 1270 Don ~-• s Lane ~- Conway, AR 72032

1} There is no qualification of all process. 2) The process was viewed in person as a staged process on 08/11/15. Additionally, video of the process occurring for production of HCG/B12 FOP- 10ML CONCENTRATE lO,OOOU {Lot Number: 20151008@5) during 08/10/2015 was reviewed. The following process was observed whereby the Ill ====~------~~ a.

b.

c. d. e.

f.

g.

h.

3) Per your Quality Control Director, room certification and smoke studies for the ISO 7 Clean room were not performed during the operation of the (b) (4 .

OBSERVATION 5 . Written procedures for sampling and testing plans are not followed for each drug product.

~SIGNA'TUllE il'ITI! ISSUI!D SEE REVeRSE Massoud Motamed, Investigat or 8/21/2015 Of THIS PAGE Lloyd D Paynd, Investigator r-_...... ,.__ ~ ~-...... :. .--~c-.:I'~· ~..I ..~T...._., J~,.....--=--- i.WA.~--·~~TIII~--·---~ DEPARTMENT OF HEALTH AN:J HlJM..\N SERVlCIS FOOD AND DRUO ADMJNIS'IRATION Expressway, Suite 300 3006031901

. US Compounding I nc. 1270 Den 's La ne

Conway, AR 72032 Outsourcing Facility

Specifically ~ you failed to conduct a 100% visual inspection of Papaverine 3.6mg/mL + Phentolamine 0.4mglmL + Atropine 0.04mglmL lot 20152403@12 prior to its initial distribution of vials on 4/16/15 as office stock. SOP Sl9 entitl~ Finished Product Testing Requirements, states in Section 9.1, cornp

Furthermore, during the visual inspection of the subsequent lot of Papaverine 3.6mglmL +Phentolamine 0.4mg/mL + Atropine 0.04mglmL lot (b 4 (b)(4) v1as found on 8/18/15 to have failed visual inspection with a failure rate of 57.5% with 114 units passing and 73 units failing visual inspection due to visible fiber like particles.

OBSERVATION 6 Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in~process material and the drug product.

Specifically, review of2015 complaints revealed that 55 of 108 of the firm's complaints relate to broken testosterone, estradiol, and progesterone pellets. When dbcussed with you firm they stated that a e number of formulation changes have been made to the testosterone pellets in order to address the complaints. However, your firm released batches of pellets without assessing the manner these formulation alterations affected product efficacy. In addition, no dissolution studies were conducted. An example of these alterations for Testosterone 200 MG Pellets is listed below:

1) Lot 20132210@12 is formulated with Povidone, Stearic Acid and Testosterone. 2) Lot 20141002@37 is formulated with Stearic Acid and Testosterone. 3) Lot 20141508@35 is formulated with Stearic Acid, Testosterone and Magnesium Stearat~.

~SIGNATU\E a-.TE ISSUED SeE REV::RSE Massoud Motamcd, Inve stigator 8/21/2015 OF THIS PAGE Lloyd D Payne, Investigator

I'IU:\'IOUII EJ:>moNOBSOUl'IJ! INSPECI10NAL OBSERVATIONS PAGE a OF 11 PAGES f • ._._...... _.• ._.,._~..... ww~-.ww ..,.,!E.-:.~·~ .....~~ ...... -owm - -'JC ;n - iiiiiti_ _liii_iAND_ :pj:,.o_iim:i_m,_lF_..r-_·-_--_·"'_.. _""''_nE'_P_AR_'i_=M...:iFOO:..;:NI-.;:;"cD~· o~;::;;HEAL= AND DRUG"' ":..;:'T.:.: ADMJNIS"I'RAu:;:;'ANn:..;:.,...:.;;;;;.;ii.:.:'UM'..\'"N'~TJONiii- msE'[iS:R.-avFiiiciii'ES-:~~ ~--~~----~.... _ -_-_~~--~--~~ t~ D AND D11 OF ~040 North Central EApressway, Suite 3 00 8/10/2015-8/21/2015* Dallas, TX 75204 nr I (214)253-5200 Fax: (214)253-5314 3006031801 Ili ! IWiEAND"t ,fU!Oji INOi\lkltiAL to Wlai llfll&T IS8UEO 1 Eddie W. Glover , CEO I Co-Owner ~~~ I US Compounding Inc. 1270 Don' s Lane I ~~~.Mn~~c.M~w------1-=~~~~~~-~~=•w=------~~ Conway, AR 72032 Outsourcing Facility

4) and Magnesium and a ~~--~~~~~~~~~------~ 5)

OBSERVATION 7 There is no written testing program designed to assess the stability characteristics of drug products.

Specifically, we observed the preparation of Morphine 2mg/2ml (lmglml) PF (preservative free) (Lot ! Nt!IDber: 20151008@2) on 08/ 10/2015. This procluct is assigned a 180 day BUD without supporting stability data. Additionally, according to your firm's production logs, other examples of products assigned a BUD of 180 day without supporting stability data include Betamethasone PF 6MGIML (Lot Number: 20152602@19) and Cupric sulfate pentahydrate PF (Lot Number: 20150402@5) 1.57 M.

Your firm's VP of Operations indicated that approximately H4 sterile products are produced by your firm. The fum indicated that of all the products produced, only two (methylprednisolone acetate 80 mg!ml + Lidocaine 1% and Medroxyprogesterone acetate 150 m~ + Lidocaine 1%) are supported by stability indicating studies. AdditionaJly, of the approximately ><" sterile products, only 17 have end- point sterility (performed for b 4 ).

OBSERVATION 8 Equipment used in the manufacture, processing~ packing or holding of drug products is not of adequate size wtd suitably located to facilitate operations for its .

Specifically,

Your finn €;mploys a b watP.T system for a b} 4 used for cleaning of instruments, beakers, and fmal containers/closures used in aseptic processes. Your H4 water system is inadequate due to the following:

EMPLO'IEE(S) SIGNATI.R! SEE REVF.RSE Massoud Motamed, Investigat or OF THIS PAGe Lloyd D Payne, Investigator - ,...... _,.~...,.---~1"8.. ._.....tL~ IMI'-~~~~---r ..~ .... _...._.~------DEPARTMENT OF H.EAL711 AND HUMAN S!RVICES FOOD AND DRUG ADMINlSTRATlON 01 ~ 4040 !lorth C..:entral '!:xpressway, Suite 300 8/10/2015-8/21/2015* Dallas, TX 75204 Fe...- (214)253-5200 Far.: (214)253-5314 3006031801

i Eddie W. Glover , CEO I Co- OWner ~ ,_,_ $TMIET AllllREB8 'l 1US Compounding Inc. 1270 Oon ' s Lane • CITY. 81'A~. z...... ,.,_ ~ TYPE I r ,_..,.., <:U Conway, AR 72032 Outsou rcing Facility

A. Your finn lacks qualification or validation for the water system, ciespite your fum utilizing the system in the production process since August 2012. B. Testing for water quality was not conducted prior to the previous (b) (4) I· Per testing by ~b) (4) J, the water failed conductivity tests. This apparent failure was not identified by your finn until FDA investigators addressed the issue v11ith the fum. C. There are no filters on pressure reJief valve for the holding tanks to prevent intake of C(Jntaminants.

OBSERVATION 9 Testing al.".d release of drug product for distribution do not include appropriate laboratory determination of ~tisf.actory conform!lllce to the final specifications prior to release.

Specifically, on 08/14/2015, your VP of Operations indicated that they produce approximately sterile drug products containing presertative; however no preservutive indicathtg studies have been p ormed. Your firm failed to test tho p~servative content in batches at time ofrei~.

OBSERVATION 10 The labels of your outso1.1J'f;ing facility?s drug products are deficient.

Specifically, the following infonnation is not found on some of your drug product labels: • The statements "This is a compounded drug" and ''Not for resale."

a The containers of some of your drug products do not contain information to ft.ciJitate adverse event reporting: www.fda.gov(medwatch and l-800-FDA- 1088. Examples of.-'.rug product labels 9nd containers that do not contain the above information:

911'1.0YtE(S)aiOHo\ll.llE " • -~ · . ?<.""J . nt.Tl! ISSUED ~ SEE REVEHSE Massoud Motamed, Investigator /.~~ : ·~-?''- . 8/21/2015 J t)F TH!S JJAGF. Lloyd D Payne, I nv~st igator !'~"' ' X . .

!I .,~ - - .....___ ! I ffllllM FDA w lllt/11) I'IBV!Ol/S l!lll'llOH 08D.I:1E INSPECrtONAL OBSERVATIONS PAGE 10 OF 11 • ~~------,~------~·------~------~------~~ PI!SIRICr ADORElSSANO Uf\1101!11} ut-I~ 4040 N? rth Central E~pr~ssway, Suite 300 B/10/2015-8/21/2015* Dallas, TX 75204 ffi ~ Ii ( 214)253- 5200 Fax: (214)253-5314 3006031801 I I ---1..--.-----, F-- STREETAilllRI

A. Pain Cream #600- Tablet-Based Formula, Melcxicam 0.09%, Topiramate 2.5%, Gabapenti11 6% in Lidocaine/Prilocaine 2.5%/2.5% B. Testosterone 20% Gel, 30 OM C. Diethylstilbestrol 0.5 mg Capsule D. Enrofloxacini..

OBSERVATION 11 Your outsourcing facility has not submitted a report to FDA identifying product produced during the previous six I months as required by section 503B(bX2XA). I Specifically, the following products were produced and not identified on your report for the reporting period I 12/1/14-5/31115, which was submitted on June 19,2015:

A. Pain Cream #600- Tablet-Based Fonnula, Meloxicam 0.09%, Topiramate 2.5%, Gabapentin 6% in Lidocaine!Prilocaine 2.5o/o/2.5% : Lot Number 20151008@10, Expiry Feb. 6th, 2016, Shipped 08/20/2015 00 B. Testosterone 200/o Gel, 30 GM : Lot Number 20151607@31, Expiry Jan. 2 , 2016, Shipped 08/20/2015 C. Diethylstilbestrol 0.5 mg Capsule : Lot Number 08052015@66, Expiry Feb. 1'\ 2016, Shipped 08/19/2015

*DA'I');S OF INSPECTIOP~ 8/1. 0/2015(Mon),8/11/20 15(Tue),8/12/20 15(Wed),S/13/20 lS(Thu),S/14/20 15(Fri),8/17/20 15(Mon),8/18/ 201 S(Tue),8/19/201 S(Wed),8/20/2015(Thu),8/21/20 15(Fri)

~'*I.OYEI!(S) -TIJAI! ISEE REVERSE Massoud Motamed , I nvestigat o r [ OF THIS ?AGE Lloyrt D Payn~ , Inve~ ti gator

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