FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS AND PHONE .

DEPARTMENT OF llEALTH AND HUMAN SERVICESFOOD AND DRUG ADMINISTRATIONDISTRICT ADDRESS AND PHONE NUMBEROATE(S) Of INSPECTIONIf6000 Metro Drive , Suit 1 01Balti more, MD 2 1215(410) 779-5455 Fax : (410) 779-5707Industry Info r ma tion: www. f da. gov/oc/industry09/21/2015 - 10/07/201 5*A;INUMBER3004562873NAME ANO TITLE Of INDIVIDUAL TO WHOM REPORT I FEOTO:Mr. Thomas J . Wilson PharmD., OwnerFIRM NAMESTREET ADDRESS1384 Cape Saint Claire RdAnnapolis , MDProducer of Sterile and non-sterile d rugp rod ucts21401This document lists observations made by the FDA represcnta ive(s) during the inspection of your facility. They are inspectionalobservations, and do not represent a final Agency determinatidn regarding your compliance. If you have an objection regarding anobservation, or have implemented, qr plan to implement, correbtive action in response to an observation, you may discuss the objection oraction with the FDA representative(!) during the inspection orjsubmit this information to FDA at the address above. If you have anyquestions, please contact FDA at the phone number and address above.IIIIIDURING AN INSPECTION OF YOUf FIRM WE OBSERVED:OBSERVATION 1,Procedures designed to prevent : icrobiological cootamr' ation of drug products purporting to be sterile are not established. ·Specifically,1On 09/22/20 15, during the prod ction of Glutathione 200mglmlInjection, lot II 88208, the following aseptic techniques were1observed in the cleanroom:1A) An aseptic operatorI observed placing anISObench top inside the5 LAFH withoutThe operator proceeded to exit the cleanroom fully gownedand walked into the adjacent unclassifiedarea to wash.hands and ands with a paper towelbefore returning back into the unclassified "clean room". Tb.i.iharmacist was then observed putting on sterilebare left hand to fit into the glove.gloves. However,. as observed adjusting the glove with.B)'·An aseptic operator observed introducing material, such asthe hood without disinfecting these materials. !The operator did notthe hood to grab material from shelves that are located in the cleartroom.r ., . ,.,intoout ofC) Another aseptic operator was also observed inh-oducing material into the hood without disinfecting the surface andalso not disinfecting! gloves when going b ck into the hood. This phannacist was producing ALFA-2B I millionuniVml ophthalmic.D) An aseptic operator w observed walking multiple times into and out of the unclassified "clean room" withoutputting on any appropripte gowning. Additionally, there is no procedure in place for gowning and no gowninginstruction in the gownmg area.IE) The ISO 5 LAFH is hoJsed in an unclassified room.,lIEMPLOYEE(S) SIGrl\JRESEE REVERSEOF THIS PAGEOATE ISSUEOA.lNebilOumer , InvestigatorQin Xu, !I nvestigator10/07/20 15'FORM FDA (O'J/08)PRfVIOU EDfTIONOBSOLE'T'f!INSPECTIONAL OBSERVATIONSPAGE I OF 6 PAGES

DEPARTMENT 0 HEALTH AND HUMAN SERVICESFOOD AND DRUG AOMJ'NISTRA TIONDISTRICT ADDRESS AND PHOI'IE NUMBER0/,TE(S) OF INSPECTION6000 Metro Drive, Suit e 101Baltimore, MD 21215(410) 779 -545 5 Fax: (·flO) 779-5707Industry Information: ! www.fda . gov/oc/industry09/21/2015 - 10/07/2015*FUI'IUMilER300 4562873NAME AND TITlE OF INOIVlDU.\L TO 'M10M REPORT l SSUEOro :FIRM NAMEMr. Tho s J. Wi s P h a r m D - · O w n e r - ----------------- STREET ADDRESS, Inc .11384 CapeSal nit C 1 a i r e R d -----------i ---------· ,-- E m PE Annapolis, MD21401Producer of S terile and non-sterile drugproductsOBSERVATION 2Procedures designed to prevent l11icrobiological contamination of drug products purporting to be sterile do not includeIadequate validation of the steriJization process.Specifically,after the sterilization5 and 8/5115) and Dexamethasone acetate(onhasofTriamcinob ne diacetatethe product shouldstability of the prod uct afterID) No media fi ll has bee; conducted that s imulatbs routine aseptic operation.IEMPlO'Yl;E(S) S!SEE REVERSEOF THIS PAGE1\IREOATE ISSU 0Nebil At Owner, InvestigatorQin Xu, InvestigatorINSPECTIONAL OBSERVAT IONS10/07/2015PAGE 20F 6 PAGES

DEPARTMENT OF; HEALTH AND HUMAN SERVJCF.SFOOD AND DRUG ADMINISTRATION0 TE(S)09/21/2015 - 10/07/2015*6000 Metro Dr ive , Suite 101Baltimore , MD 21 2 15(410) 779- 5455IndustryOF INSPECTIONFEI NUMBER300 4562873Fa x: (4 1 0) 77 9- 5707Informa t ion : , www . fda . gov/oc/ ndust r yNAME ANO Tm.E OF INOIVI.DUAL TO 'NHOM REPORT) SSUEDTO:IMr . Th omas J . Wil s on PharmD .,IFlRMNAMEO ne rSTReET AOORESS1384 Cape Saint Cl aire RdCape Ap othecary, Inc .TYPE ESTABUSHMEHT INSP CTEOProducer of Ste r i l e a nd non- s teri l e d rugp roduct sOBSERVATION 3Each batch of drug product purporting to be sterile is n t laboratory tested to determine confonnance to such requirements.Specifically,A) Mr. TJW stated that sterility/and endotoxin testingendotoxin test result certificates' of recentlyendotoxin samples have not been sent to their contractsterile products are conducte basis. However,products could not be produced by the firm. Mr. TJW stated that ab I ltOl"f for the past 9 months.on all sterile drug products produced by your ftrm. Instead. .uuC) Sterility samples are incubatedsterility samples usingFurthennore, sterility san1pJc ssterility test.in-house; however, the finn did not evaluate theintended to support anaerobic microbes.is no data that supports the validation of theOBSERVATION 4optDrug product containers wereclean and sterilized and processed to remove pyrogenic properties to assure that they aresuitable for their intended use. ISpecifically,On 09/22/2015, ausedmanuthat all glassware I beakers are washed withtesting is conducted on a basis wn,P rPin e-.oYEE!Sl SIGNAl\JRESEE REVERSEOF THIS PAGEFORM FDA 113 (09/08)IOATEISSUEONebil A. Oumer , I nvestigatorQin Xu , InvestigatorPREVIOUS EDITION OBSOLETE.,INSPECTIONAL OBSERVA:fiONS10/07/2015PAGEJ OF 6PAGES

- 10/07/2015*30045 62873PharmD.,, Inc . 'of Sterile and non-sterile drug21401roductsOBSERVATION 5jAseptic processing areas are de cient regarding theaseptic conditions.for cleaning and disinfecting the room and equipment to produceSpecifically,IThe following non-sterile disinfectants are used for san zing the ISO 5 LAFH and the surrounding unclassified "cleanNo efficacy study was performed to determine if theselevel in the ISO 5 LAFH and other surfaces (i.e.OBSERVATION 6Clothing of personnel engaged ih the manufacturingperform.processing of drug products is not appropriate for the duties theySpecifically,On 09/22/2015, two aseptic opebtors were observed .rtnnni aseptic operations in the ISO 5 LAFH wearing non-sterilegowning. Specifically, their coat, face mask, shoeand pants were not sterile. Additionally, their face mask did notCOVer their skin around their rnrPni JnOBSERVATION 7JProcedures describing the calib?tion of instruments,gauges and recording devices are not written or followed.Specifically,There are no calibration and qualification records forfollowing equipment:however, nolncubato ) used for incubating passive air samples, sterility samples andAdditionally, there is no procedure in place for caliSEE REVERSEOF THIS PAGENebi l A. Oumer , InvestiQin Xu, 1 Investigatorand qualification ofthe above listed equipment.10/07/2015PAOE 4 Of 6 PAGES".

- 10/07 /20 1 5 *Ann a polis , MD2 14 01of St e ri l e and non- ster i l e drugOBSERVATION 8for monitoring environmental conditions.Aseptic processing areas are deficient regarding theSpecifically,in the IS05 LAFH during aseptic operations.B) Personnel monitoring is conductedair sampling is conducted on thewithLAFH,Passiveroom"C) AnExp. Date 04/09/2015) used for passive air sampling and forfingertip testing was observedOBSERVATION 9A se.p icprocessing areas are derycient regarding airpos1t1ve pressure.that is filtered through high-efficiency particulate air filters underSpecifically,operations was conducted onic conditions. According to Mr.OBSERVATION 10There is a failure to thoroughly t1eview any unexplainedmeet any of its specifications whether or not the batchSpedfically,Iand the failure of a batch or any of its components tobeen already distributed.jNo investigation was initiated to determine the root cause for several potency failure resu Its for products produced in 2013,20 12 and 2011. For example, Diethysltilbestrol lmg (l t # 49011 , dated 10/10/ 13), "Bactroban, Sporonox, Triam, Xylitol"(lot # 20085, dated 5/3 1/ 12), and Bactroban Nasal Spray 0.2% (lot# 2040103, dated 6/6112) had the following potency11results: 80%, 80.5%, and 53.5% respectively, against a pecification o Furthermore, there is no procedure inplace for conducting investigati ns.SEE REVERSEOF THIS PAGENebil AJ oumer , rnvesti j atorQin Xu , Investigato r---- ----'--------- -------·- ---10/07/20 15

DEPARTMENT HEALm AND HUMAN SERVICESFOODOISTIIICT AOORESS ANO PHONE NUMBERDRUG ADMJNJSTRATION01\Te(S)''6000 Metro Drive, Suitle 101Baltimore, MD 21215(410) 779- 5455 Fax: (410) 779- 5707Industry Informat ion : www.fda.gov/oc/'ndustry INSPECTION09/21/2015 - 10/07/2015*I'El NUMBER300 4562873NAME "-NO T1Tl.E OF INDMOOI\1. TO 'MiOM REPORT ISSUEDTO :Mr. Th.9mas J. Wilson PharmD., Ow nerFIRM NAMESTREET ESSiCape Apothecary, Inc.1384 Cape Saint Claire RdCITY, STATE, ZJPOCOE. COUN'mVAnnapolis, MDTYPE ESTA.BUSHMEHl' INSPECTED21401Producer of Sterile and non - sterile drugproductsOBSERVATION 11There is no written testing program designed to assess t e stability characteristics of drug products.Specifically,The finn does not have a stability program for sterile 3IJ d non-sterile drug products manufactured at this site.Hydroxocobalamin (B 12) 3000 MCG/ml injection. Tob ramycin (Ophth) l5mglml Drops and Cisapride 5mglml suspensionhave an expiration date of 6 months, I month, and 2 me ptbs respectively.J*DATES OF INSPECTION:0912 1120 IS(Mon), 09122120 IS(Tue), 09/28/20 IS(Mon), 09/2 20 15(Tue), I 0/06/20 I S(Tue ), 10/07/20 15(Wed).lI.' II.IIIEMPI.DVCE(S)SIGHATVRESEE REVERSEOF THIS PAGEFORM FDA 483 (09/08)Nebil A. Oumer, Investi gatorQin Xu, , InvestigatorIPR.eV10t1S .EDtT10N OBSOt.ET'E '?a---- INSPECTIONAL OBSERVATIONSDATE ISSUED10/07/2015PAGE 60F6 PAGES

Annapolis, MD 21401 . . ISO . 5 LAFH without The operator proceeded to exit the cleanroom fully gowned and walked into the adjacent unclassified area to wash. hands and ands .