DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION 4ni2i2021 — 4720/2021 ‘DSTRET OFFICE ADDRESEANG Baltimore Distict (@LT-0O) 600 Woo Dive, Sute 101 2s Batimore, MO 21248 Fenamer aio) 778-5489 xebonspectonaeoresgondence Ska hs. gov __[s0r54aseos AME AND TITLE OF NOVASUAL To WHOU REPORT Is SSUED TO: Dino S Muzzin, Senior Vice President Manufacturing Operations Emergent Manufacturing Operations Baltimore, LLC. 5901 Eat Lombard Street THY, STATE AND 2P COE - TYPE OF ESTASUSHIART HGPECTED \Vaceine Orug Substance Manufacture z ie PECTNOFs BEE NATON REPO YOUR COP ‘AVE one ON Acton NaeaPene Tun CHSNUATON OL Mu OLAS re CREST Observation 1 Failure to conduct thorough investigations into unexplained discrepancies, Specifically, a The cross-contaminat 28) viral vaccine drug substance batch (BY(AYEE. which was ‘manufactured betwe nd (BAY. with the virus from client @) as described in deviation 3100012112 initiated on 3/17/2021 has not been thoroughly investigated. Specifically i. The deviation did not include consideration of operator 84@) who is recorded on the batch record as weighing and dispensing the raw materials for media batch (BY(AYEN used in the ‘manufacture of # batch(BYI@YE Yon {BYMAYE. This batch of media is implicated by your firm in the deviation as the most probable cause of the cross-contamination event. Operator {PHG) also entered both manufacturing areas where client PM viral vaccine drug subst and client M4 viral vaccine drug substance are respectively manufactured on (BYGY I 0 tsb ons a ‘video surveillance. Operator ®M@} was observed on the security camera footage dated | vearing protective gowning and foot protection inthe controlled not classified hallway outside the (B)@) room before entering the (BYE) room through tne (BY) ji, The deviation investigation did not include a thorough review of personnel movements in and around the facility as a potential source of contamination, iii, The deviation did not include consideration of the potential impact of the continued use of | to store raw materials used to nonhce used in the | manufacture of client 4 viral vaccine drug substance and client ™® viral vaccine drug | substance. These EEE were identified in the deviation as being not desig allow for proper decontamination. iv, Itis not known how long client (44 virus will remain viable on a surface. There was no | | additional cleaning performed other than the routine cleaning in response to this deviation. There is no assurance that other batches have not been subject to eross-contamination ed to >. Or{BPN4VNE 1, during the filling of batch (BY(4YHY bulk drug substance for client PHM released on )@) Ab) 4) leak was observed by the operator. The fill recipe was paused and lawes a [i ee it ‘aml so Ccovotmcmen erga | fie Ne 2 a ree [ Forwron a6 e108) eevous enon oxs00eTE INSPECTIONAL OBSERVATIONS PaganDEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION. LaigTRCT OF TICE ADDRESS ANG PHONE NUMBER | BRTERIOF NEPECTION— Baltimore Distict (BLT-D0) artzrzaa' ~ 47202021 | 6000 Metro Orve, Suite 101 Baltimore, MO 21215. FETNONER cia maee seta sa wees 2 2 aa RES To: One’ en, Src Ves Mende Nanci Opetone re EET ORE EnogetMandicirg Opn Btina Lc. __| 260 Eason Shea ar MOTE FES EES otro 220 | vein ng anne ance TUE aT GET OR SUB TH RFORUATONTOFOAAT TE SCORES ECVE YOUVE A GLESTINS, PLEASE CONTAGT Om AT PHONE MNEERAND CDHES ED sas (OV(AYN theB\GNNN MN. hen the recipe was aborted, end a new recipe was initiated. The practice for aborting a fil is not described within a writen procedure and is not a procedural step in the master batch record. Your firm failed to investigate how the ‘operators were trained to perform this recipe abort and initiate a new recipe technique. Your firm also failed to investigate what impact utilizing this technique has on the product during filling operations. ©. On 1/19/2021, (GMA) room 1D KA ond (BY) coricor 1D ba lozbook envies “fis (EINE 2nd “repair MIN The balks crue substance bateh(BY(AYIN tor ction BH, released on {6){@JNN, was in the (B)(4)| at the time of these logbook entries. Your firm failed to initiate a deviation and failed to conduct an investigation to evaluate what impo | had on balk drug substance batcHB)(4YEEE or what corrective actions were initialed Observation 2 | The building used for the manufacture of the client @M@) viral vaccine drug substance and client ®OBviral | vaccine drug substance is not maintained in a clean and sanitary condition. Specifically, ‘a, Waste generated during the manufacture of the client €4@) vaccine drug substance and client (4) viral vaccine drug substance is not decontaminated using (BY(4)im—l that have been qualified tor use or 8)(4) qualified for actual use. Such waste is transported through the warehouse before disposal and has the potential to contaminate the warehouse and adjacent areas >. The manufacturing rooms and corridors are not cleaned with : ‘c. The painted floors in the warehouse were observed to be peeling on multiple days durin inspection. Large areas of the painted surface are missing in front of the and (©) YEN sampling rooms. ‘The damaged floors and rough surfaces do not allow for adequate cleaning and sanitization. = Ee ore RTS ne |@ ss Erannean ane ey os %, Soyo acoasisigr | — Jererny Wally, Senior Advisor See TE 7 —DEPARTIENT OF HEALTH AND HUMAN SERVICES FOOD AND ORUG ADMINISTRATION DATES) OF NSPECTON ‘DISTRICT OFFICE REDRESS aR PORE WINBER ‘ari2202% ~ 42072021 Baltmore Distict (BLT-00) 8000 Metro rive, Sute 101 Baltimore, MD 21215 (410) 779.5455 NATE AND TUE OF ROVINAL 70 YOU REPORT IS ISSUED. TO: Dino S. Muzzin, Serior Vice President Manufacturing Operations 3015448605 Emergent Manufacturing Operations Baltimore, LLC ‘5001 East Lombard Streat TAY, STATE AND 2 CODE Batimore, MO 21224 TYPE OF ESTABLSHUENT MSPECTED Vaccine Drug Substance Manufacturer TS DOOM USTs DERN HATE BYE FIX REPREOEATNE DRG Te RSPECTIONOF YOURTACLY. THEY SE RSTECTON CHSERTATONS OTTO REPRESEN" APL AGENCY eaNn on eA YOUR CEMPLANE.FYOUIMVEAUCAIECENSeGARGNG A OBGERIATIN OR AE MPT! Mew, coneecve scron eaPoxse TON BSE RUAN YOU MAY Bac WE O8=ETION OR TN moe a AeesenTAT Ct) URN pas ace ee ree Pee ene ere aie cians Seco rwsnravecomnen: d. On 4/14/2021, the paint on the walls of the controlled not classified corridors surrounding the ‘manufacturing rooms for Areas ffandfi@were observed to be peeling in multiple areas. Paint flecks ‘were observed on the floor all along the sides of these walls. Damage to the wall boards was also observed approximately 6 inches above the floor and approximately 3 feet above the floor. This peeling paint and wall damage impacts the firms’ ability to adequately clean and disinfect the area, €. 0n4/14/2021, the following items were observed inside room EBB, a Grad Be diving the filling of clien 2M viral vaccine drug substance batch [EAI i. Paint flecks, loose particles/debris, and a washer were observed on the floor along the sides of he wall ii, Brown residue was observed on the wall iii, Black residue from alINRMIJ was observed on the floor iv. Blue peeling paint was observed along the door jam into room (OH Observation 3 ‘The building used for the manufacture of the client BUM viral vaccine drug substance and client f@viral vaccine drug substance is not of suitable size, design, and location to facilitate cleaning, maintenance, and proper operations. Specifically, ‘a, The number and size of decontamination (B)@)EE used to decontaminate waste generated during the manufacture of client PM viral vaccine drug substance or client viral vaccine drug substance are inaclequate to ensure that such waste is decontaminated ina timely manner. In addition, an assessment of the building’s capacity to decontaminate waste was not performed as part of the incoming process gap assessment prior to introduction of the manufacturing of elient 19 viral vaccine drug substance into the facility ‘The inadequacy of waste handling is underscored by planned deviation 3100012410 that was ‘opened on 4/9/2021 to change the path of waste out of the building for Areas Mand and due to an increase in waste from Areag®)(@) and fis waste will not be(B) (AYE. but it will be(BY@) bagged and the exterior of the bag will be with (BY) prior to transport through the warehouse and out of the building for a limited number of days. FE TRRLOPEES CoN URE BETES NE ANDTHE i Tp [OATES fevense | Wels ary a Debra Emerson, nvstiatr | taoaoat eas | Gh G20) 9: Rickman, investor | abe Sere Waly, Seis Ace | Fon Fon a wan) _Aeviouseomow nsDuFTE INSPECTIONAL OBSERVATIONS Payeich 17[DEPARTMENT OF HEALTH AND HUNAN SERVICES FOOD AND DRUG ADMINISTRATION. | DISTRI OFFICE AGGRESS AND PHONENOWGER DATES)OF RSPECTION Baltmore District (BLT-D0) ‘arize02' ~ 472072021 16000 Metro Orve, Suite 101 Baltimore, MO 21215, OER (410) 779:5455___oraboinspectonslconespondencedhtsa ns cov 3015448605 NAME AND TITLE OF HOWDUN. To WHOM REPORT ISSUED TO: Dino S. Muzzin, Senior Vice President Manufacturing Operatons FRE ‘STREET ADDRESS - Emergent Manufacturing Operatons Baltimore, LLC 5901 East Lombard Street TAY, STATE AND 2 CODE “TYPE OF ESTABLISFWENT INSPECTED Baltimore, MO 21226 Vactine Drug Substance Manufacturer [is ooeuwenT cas cae TERE WIOE BIE FER REPRESENTA WEG IANS i RPTCTON OF VOURTAGUTY TEV REPRESENT APWOL NENG TE AURGTIONRERON YOUR CONPLANGE.F YOUVE A lc on EOE A EEA Meer coc Ase eSPoNSe TAN OBEERVAIN YOU AY DSI ME CLECION BRATION Fae SEMTATtS) te he NSPESTN MESS ADE YOU AE AY LATOR EASE CONAGT FAT ME POE MASER ND CHESS ABOVE URN A SFECTONGs YOUR FAME OHSERVED b. The warehouse was observed on 1/27/2021, 2/3/2021 and 2/4/2021 through security camera footage, and on 4/12/2021 and 4/13/2021 through direct observation, to be overcrowded with ‘materials staged for entry into manufacturing as well as material staged for QC sampling. ©. 0n4/14?2021, the Area (SU@YEED. room PNA), was observed to be congested with and containers used 0) | a 0n.4/14/2021, the Arca (BHA), room WE. was observed to be congested with carts transport racks for INE ug substance, INI contsiners used to bo A 33 drug substance, and various other pieces of equipment. The congestion made it difficult to move ‘without bumping into equipment or fe, The doors into and out of the (B)(4) NNN into the (BPA) NNN area and into the (GENE area are too small as operators are unable to use a pallet jack for pallets to move material in large containers. On 4/12 and 4/13/2021, operators were observed pushing and pulling large containers along the floor to move them from (@)(4)INNNEENE Foor and (©)(4) H room into the warehouse. Observation 4 Written production and process control procedures to prevent cross-contamination are not followed in the execution of production and process control functions and are not documented at the time of performance Specifically, a. According to security camera footage from 1/27/2021 and 2/3/2021, employees handling special medical waste from manufacturing Ared# where bulk drug substance for client (4 is manufactured, failed to follow SOPO41888 v 3.0 (effective 8/21/2020) regarding handling non- disinfected and non-decontaminated special medical waste. see = sonarge TUPLOYEEIS RANE AND TCE (oa pn) OATES REVERSE Debra ml. emerson, Investigator anno cones ‘Cody D. Rickman, investigator Jromy Wally, Senior Advisor ‘FORM FOA 4836108) _ PREVIOUS ae ae sPECTIONAL OBSERVATIONS Pagel[DEPARTMENT OF HEALTH AND HUMAN SERVICES. OOD AND DRUG ADMINS RATION | | DSTACT OFFICE ADDRESS AND PHONE WONDER DATEIS|OF NSPETION Baltimore Osstnct (BLT-00) ‘ar2r202' ~ a’z012021 £6000 Metro Orve, Suite 101 shines | Baltimore, MD 21215 FENOWER | 410) 779-5455 . inal 3018488609 To: Dino S. Mutzin, Senior Vice President Manufacturing Operations FRE “TIREET ADRESS Emergent Manufacturing Operations Batimore, LLC. ‘5901 East Lombara Street ‘IY, STATE AND 2 COTE TYPE OF ESTABLSHONENT WGPECTO a Battimore, MO 21226 ‘Vaccine Drug Substance Manutacturer [SOREN SS OREUATRS TET TIVES ORGY PED ONCE VORTAC TYRE SPEIER ae a ee ee ee ne een Seamer enaltaer see neem enn eas mc anererncronnene cen i. On 1/27/2021 and 2/3/2021, employees in manufueturing Area ftwhere bulk drug substance | for client @@) is manufactured, were observed throwing unsealed bags of special medical waste into the service elevator accessing the warchouse corridor ii, On 1/27/2021 and 2/3/2021, employees in manufacturing Area fifwhere bulk drug substance for client His manufactured, failed to [MH all special medical waste with (On 1/27/2021 and 2/3/2021, employees were observed carrying unsealed bags of special medical waste from manufacturing Arealf® The unsealed hags were observed contoeting containers of staged manufacturing materials, walls, and fence barriers in the (BYX4YIN (HAY corridor of the warehouse iv. On 1/27/2021 and 2/3/2021, employees were observed dragging used materials containers and unsealed bags of special medical waste from manufacturing Area across the floor of the (G)(@)EENE MEN corridor of the warehouse. v. 0n 2/3/2021, employees were observed compacting, using their gloved hands, unsealed bags of special medical waste from manufacturing Area Min the warehouse where raw materials were staged for manufacturing in Arca for client ®2) vi. On 2/3/2021, employees were observed removing their outer protective garments onto the ‘wurehouse floor where raw materials were siaged for manufacturing in Arca fifor client ‘and placing the garments in open garbage containers. 'b. According to direct observation and security camera footage from 2/4/2021 and 4/12/2021 employees handling raw materials intended for the use in manufacturing Area where bulk drug substance for client @Y@Pfuiled to follow SOPOO1518 v 15.0 (effective 4/9/2021) and SOPODISI$ v 14,0 (effective 9/3/2020) regarding the handling of materials into the (BY(4YENNNENENE room and th6Y@)EEEE sampling room. i. On 2/4/2021, employees were observed dragging containers of raw materials aeross the floor of the (B)(@)E TENN warehouse corridor failing to apply MMM 0 the bottom of the container. ii, On 4/12/2021, employees were observed dragging containers of raw materials across the floor of the (BYGYNENENEEN warchouse corider oor failing to apply EE 0 the bottom of the container. TIPLOVEETS RANE ANDTHE Paro) [ARTE TRSUS ‘se [Ot UA a Se ee Jeremy Waly, Senior Advisor ‘FOR FOA 485(0108) _PREVOUS FOTION OSOLETE TNSPECTIONAL OBSERVATIONS Panes 1Di DEPARTMENT OF HEALTH AND HUMAN SERVICES. FOOD AND DRUG ADMINISTRATION ST RTT BRST Sracoac aa Tae aaah Sse See eh igen as aes TIE AN TTLE OF NOWADOAL To WOM REPORT Is 6SUED To: Dino S. Muzzin, Senior Vice President Manufacturing Operations FRAN ‘STREET ROORESS Emergent Manufactuting Operations Baltimore, LLC. 5901 East Lombard Sieet TAY, STATE AND 2 CODE “TYPE O ESTAALISHUERT NSPECTED - Baltimore, MD 21226 Vaccine Drug Substance Manufacturer THES DOLAENT UST SERVATIONS WADE Te TAREPRESECTATNET BURNS Tre PECTIN DF YOUR TACT. TET ARENGFEETION REPRESENT APWU AGEN UTERUMAIOU RAMOS YOUR COMPLANS. F YOUHOVE ANCOUC? CA REGAAONG NORGE we MP Mee Conmeve AEN W RESPONSE YOON OBEERATEN YOU MAY BSUS HE OBUECTON OR ACTION WTI Fos REESE AT ‘OSU TS REORUATONTOFDAATTHEAGOREES EVE FYGU NE A GLESTIONS EASE OMIA Ou AINE PHONE MAWERAN ACDRESS AOE RNG AN SFECTON = YOUR WE OBSERVED fii, On 4/12/2021, employees were observed dragging containers of raw materials across the floor of the (64) HNN NEN corridor failing o opp I to the bottom of the container. ¢. According to security badge access logs, shower logs, and security camera footage from 1/19/2021 to 2/21/2021, employees were observed entering manufacturing Area f#where bulk drug substance for client PM] and AreaMfwhere bulk drug substance for clienf@M@) in the same day failing to document de-gowning, showering, and gowning activities according to SOPOOISI6 v 23.0 (effective 2/5/2021) and SOPO01S16 v 22.0 (effective 9/2/2019). i. According to the security badge access log, security camera footage, and batch record (BUI 0n (BPA, « manufacturing associate (Operator upstream MFG) was observed centering manufacturing Area fiWwhen manufacturing for client fl] was taking place, then ER fo: #20» materials for client 8, and then loading of materials into the (GIN in manufacturing Aref for client MB without documenting de-gowning and showering. ji, According to security badge access logs between 1/19/21 ~ 2/21/21, one MFG Bioprocess Associate entered manufacturing Area! and manufacturing Arca fon the same day, during 19 different days, only documenting once in shower logbook on 2/21/21 iii, According to security badge access logs between 1/19/21 ~ 2/21/21, one engineer entered manufacturing Area Ptand Area fiton the same day, during 4 different day’, not documenting in shower logbook for any of the days, iv. According to firm management between 1/19/21 ~ 1/31/21, approximately 14 different personnel entered manufacturing Area Mand manufacturing Areafffon the same day, there ‘was no documentation of a shower. v. According to firm management between 2/1/21 —2/11/21, approximately 13 different personnel entered manufacturing Area Mand manufacturing Areafifon the same day, there ‘was only one documented in the shower logbook. vi, According to firm management between 2/12/21 ~ 2/21/21, approximately 13 different personnel entered manufacturing Are and manufacturing Areafion the same day, there were only two documented in the shower logbook. =, LEER) SNATORE GHPLOPERS NAME AWD TILE eT TESST REVERSE Ne Dobra M. Emerson Investigator noo ope D. (Zeer | ad Ficiman investor every Wally, Senior Avisor ‘FORM FDA 4839108) _ PREVIOUS EDTION OBSOLETE INSPECTIONAL OBSERVATIONS Paseo 12[DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION. ‘STRICT OFFICE ADDRESS AND PHONE WOMBER ‘DATEIS|OF INSPECTION Batmore Dstnct (BLT-00) ‘arizz02' ~ 47202021 Eatimre MD 21215 FERRET (ero) 70.658 | sotsaaacos |70: Dino S. Muzzin, Seni Vice President Manufacturing Operations {6000 Metre Dave, Suite 101 | eee ns ood ‘STREET ADDRESS Emergent Manufacturing Operations Baltimore, LLC. 001 East Lombard Street |Ony.STATEANOZ® CODE] PE OF ESTABLISHMENT PECTED Batimore, MO 21224 Vaccine Drug Substance Manufacturer ibe aoe RENT PEERS TER OR Te nercTONG TR THGLY. TYE hrecTOW ATOR NODC Tereaa crs Synge Oar Pl nae en Con ax GueueeaO Sa Seam coecne masts omveaeaenvovan oxete ts Suter orschon hse remem me He AoC Xs tar RASH OPDAT Me eS EN PL ove Cato DaAHE COTA OAN mete MAREE IE ua epecnon oun eon ‘4. According to direet observation and security camera footage from 1/27/2021 to 4/12/2021, ‘employees were observed entering the materials airlock for manufacturing Area where bulk: dus substance for client BHM manufactured, warehouse, ()4)TNNEN room, and (OVU4)S | (AEE 00m failing to adhere designated gowning zones according to SOPO0IS16 v 23.0 (ellestive 2/5/2021) and SOPO01S16 v 22.0 (effective 92/2019), i, According to security camera footage on 1/27/2021, employees were observed removing gloves and booties into waste containers located in the warehouse with staged raw materials present after handling special medical waste from manufacturing Area fl ii, According to security camera footage on 2/3/2021, employees were observed removing protective gowns onto the floor of the warehouse and into waste containers located in the ‘warehouse with staged raw materials present after handling special medical waste from ‘manufacturing Area iii. Per direct observation on 4/12/21, employees were observed wearing protective gowns and booties into the warehouse and warehouse corridor while conducting activites in the Areaff rmaterials airlock, (6){4)STEN 00m, and (6) Hl room Observation 5 ‘The components, product containers and/or closures were not handled and/or stored in a manner to prevent contamination. Specifically, Product components, containers, and closures involved in manufacturing operations, quality control ‘sampling, weigh and dispense operations are not handled and stored to prevent cross contamination of viral bbulk drug substances created for client and client (1) a, On 3/16/2021, the firm was notified by client®14) that bulk drug substance batch (64) manufactured between (BY) and (6Y(4Y, was contaminated with ABYGYTT used in the manufacture of bulk drug substance for client 4) Review of security camera footage found — ee ROGET AO TIERS ial — ESD na v ee o Epa FOR a WO) Pou COTNCNEOTE TNSPECTIONAL OBSERVATIONS PapsDEPARTMENT OF HEALTH AND HUMAN SERVICES. FOOD AND DRUG ADMINISTRATION ‘ISTRY OFFICE ADDRESS AND PHONE HOWSER ‘OATES OF RGFECTION Baltmore Distt (LT-00) ‘arrzza2' ~ 4702021 16000 Metro Drive, Suite 101 Batmore, MD 21215 FENOER (410) 776.5455 3015448605 'NAIEANO TTLE OF NDVIDUAL 10 WHOM REPORT 5 1SSUED 1 TO: Dino S. Muzzin, Senior Vice President Manufacturing Operations | Emergent Manufacturing Operations Baltimore, LLC. 5901 East Lombard Steet cI. STATE ANU ZF COOE TYPE OF ESTABLISHIRENT RSPECTED == Baltimore, MO 21228 Vaccine Drug Substance Manufacturer SETS CERT TIONS AD BY TOR RPRENEN VETS DONG Tk FSPRCTIONF YOUR GUT THEYRE ROPETTONAT OSBEATONG. RDO WOT | Rapes tc acey oma en even aNCAPLOG YD AN seTcA RenAN ONE ce | tsien congenic varen nese enn esesanon eu SceerieSeSON anAcTon mine oa perese aT DG NSE ‘to TAB FGI 1 aaAT THEADRESS ASD 110, MENT LESTONS EGE SONG" FANT THe MONE MOEN MD ASHES NOE URN LASSER YOLEN SEED. | i. On 1/27/2021 and 2/3/2021, employees were observed carrying unsealed bays of special | medical waste from manufacturing Area" The unsealed bags contacted containers of staged manufacturing materials, walls, and fence barriers in the (6) (4) corcidor of the warehouse, ii, On 1/27/2021 and 2/3/2021, employees were observed dragging used materials containers and unsealed bags of special medical waste from manufacturing Area fffacross the floor of the (B)(4)ENTNE ML corridor of the warehouse iii, On 2/3/2021, employees were observed compacting unsealed bags of special medical waste from manufacturing Area in the warehouse where raw materials were staged for manufacturing in Areal for client @4 iv. On 2/3/2021, employees were observed removing outer protective garments onto the warehouse floor and placing them in open garbage containers where raw materials were stage yr manufacturing in Area Ff for client vy. On ‘ee See was ee i material bucket containers ona table inthe service elevator accessing manufacturing Area if amongst unsealed special medical waste from manufacturing Area then bringing th{B)(@4) ll material bucket containers into the{B) (4) oom without decontaminating or disinfecting the (IGYEN materials bucket containers. vi. On 2/4/2021, employees were observed dragging containers of raw materials across the floor of the (6YGYETENENNEN warehouse corridor failing o apply to the bottom of the container. b. On 4/12/2021, employees were observed dragging containers of raw materials across the floor of the (6)(4)NNENNNN and (6)(4)NNNNNNNNNINEE warchouse corridor floor failing to apply HERB «0 the bottom of the container. ¢. On 4/12/2021, we observed(B){AYINEN material bucket containers with racked or opened closures in the raw materials staging area ofthe warehouse staged for manufacturing in Area MM for client d. On 4/14/2021, we observed employees lifting containers of (S(4)ENNNNN onto a platform, opening the container, and then using a scoop fo adé the) into thaB)(@)NN of a TaELGVEES SGRATRE___ BiPCO VEE RAGE AND TE aan) JOATE SED Tnevense ea Deore Emerson, nvesupaor | szuaozs ‘or mas D ee ody D, Rickman, investigator SZ. Stn Way Sento sas oe PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Paper 12DEPARTMENT OF HEALTH AND HUMAN SERVICES. FOOD AND DRUG ADHINISTRATION J DSTRICT OFFICE ASORESS Ano Prove NuMBER areisorinsperion Baltimore Distict (BLT-D0) ‘aratzazt ~ 472072021 | 6000 Metro Drive, Suite 101 sia | Batimore, MO 21215, TONER [cei0) 779.5455 rabloinspectionaleortespondence™@ Ida nhs gov __| 015448606 TO: Dino S. Muzzin, Senior Vice Presiden! Manufacturing Operations [rare ‘REET ADDRESS _— Emergent Manufacturing Operations Balimore, LLC. 5901 East Lombard Street ester mo. 22 | vce ng Suncare TS QOCLNENT US HRERTAT ONS CEH TED RR ‘CSUR 4s RFORUATIONTFDRAT TH ADGRESS ABOVE. TOU AME MY GLESION RGU ToeY ASPEN EUROS OTD HAVE GUEST ONS PEASE CONTACT FONAT TE PFONE MBERAND SORES AO (4) for OO) SII batch (BANE in manufacturing in Areal We observed the employees failing to remove or sanitize their gloves afer grabbing the bottom of the container. Observation 6 Written procedures designed to assure that the drug substances manufactured in the facility have the identity, strength, quality, and purity they purport or are represented to possess are inadequate. Specifically | a The procedure for decontamination of waste generated during the manufacture of the client viral vaccine drug substance and client) viral vaccine drug substance described in SOPO40195 | does not include a description of how the bags containing the waste are to be placed into the (4) to ensure that there is adequate( BJ) into these bags to decontaminate the waste. Such waste is transported through the warehouse, where raw are received and staged, prior to disposal. b. ‘The procedure used for the periodic monitoring of decontamination (PAYEE cflectiven described in BOP040102 and documented on FRMO042531 does not include a requirement for placement ofthe (B)(4) or (bY) in a (BYKAYIN location insicle the ©)@) to support that all of the waste is decontaminated. Such waste is transported through the warehouse, where raw materials are received and staged, prior to disposal ¢. The procedure for cleaning and decontamination of MM used to store and transport raw materials described in SOPO01518 does not include a requirement for cleaning the {J or to remove resid: J onto the IIREE prior to placing(5)(4) filesed to store the raw materials inside the . Such(6)(4) J were identified in deviation 100012112 as being able to introduce material on the outside ofthe J into « (BY) in which HIB sed to manufacture the client @M@viral vaccine drug substance are formulated. d. The procedure “Material and Waste Flow for Arca ft SOPO41888, version 3.0, effective 21 Aug | 2020 does not reflect current operations for the movement of contaminated waste. The procedure | states ()(@YENET all potentially contaminated waste”, however staff in Area ftwere allowed to | dispose of potentially contaminated waste without first using the (BYI@Y = PLOVER, SGRATIRE ENFLOYEEIS) NAME AND TTTE Prefer Ten) [DRTEISSUED "REVERSE =p Dobra M. Emerson. investigator szo2021 eens Cody B Rickman investigttor | remy Waly, Senior Advisor (TFomarroa a 700) pee \SPECTIONAL OBSERVATIONS Pageet 2DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND ORUG ADMINISTRATION ‘DISTRICT OFFICE ADDRESS AN PHONE NUWBER ‘DATEIS|OF INSPECTION Baltmore Dietnict @LT-00) saivarz0at ~ 42012021 {6000 Metro Drive. Suite 101 Baitmere, MD 21215 FeNOMaER | 410) 770-5456 orabloinspectionalcorrespondence@aida hhs gov 3015446005 AME AND TPE OF WIRE TO WWION EPORT 16 (SBOE TO: _ Dino S. Muzzin, Senior Vice President Manufacturing Operations Fae ‘STREET ADDRES Emargent Manufacturing Operations Baltimore, LLC 5901 East Lombard Street TY STATE AND ZP CODE — THE OF ESTABLSANENT REPECTED 7 Baltimore, MO 21224 Vaccine Drug Substance Manufacturer [7S BEELER GRE TENS WDE EPRESEO AT CRTC NaPECTIONOF YOUR. om ISRO EPEAT AA AGENCY ETERURATIONREGARDNG OR OMPURNCE. YO AES OBLEC TION ESHRGNGAN COSERATIN OR HAVE WPLEETED, RAN INPLSUNrComsecrie Aron sePONSE ‘AN aSeRIATIN YOU NAY OGOLBS THE ORIECTN OF ATION Wt Te FoR EPACS NTA oe NSPECTON (RSL a WEGruch TORDASTTHEACORESS ABOVE #YGU AEA QUESTNG, LAS CONAGT ORANG PHONE MMGERAND ADDRESS NOE DURNG AY NS>ECTINCE YOUR Observation 7 Employees were not trained in the particular operation that they performed and/or in CGMP related to their job funetion. Specifically, The firm has failed to adequately train personnel involved in manufacturing operations, quality control sampling, weigh and dispense, and engineering operations to prevent cross contamination of bulk cr substances created for client OM) and clieni@@) Review of security camera footage found: 4. Personnel involved in manufacturing operations entered manufuctur client (44 bulk drug substance was taking place, then entered (B)(4Yip Ml Ooms where operations for client) bulk drug substance was taking place without properly adhering to | gowning procedures. . Personnel involved in manufacturing operations and engineering entered manufacturing Aveaff while processing of client bulk drug substance was taking place, then entered manufacturing Arca while processing for client bulk drug substance was taking place without properly adhering to gowning procedures. cc. Personnel involved in manufacturing operations dragged non-disinfected and non-decontaminated special medical waste from manufacturing Ared##@ across the warehouse corridor, (BA) (YIN corridor, anc{S)AY NNN NNN corridor floors, failing to adhere to materials and ‘waste handling procedures. 4, Personne! involved in manufacturing operations collided with walls, warehouse barriers, (BV) (©)[A) coors (6) AYN NNT doors, and staged raw material containers with non- disinfected and non-decontaminated special medical waste from manufacturing Area ff fuiling to adhere to materials and waste handling procedures. BRIER ROUTE | ROE WES LE a —[URTEERTES Batra ners, eter pas D tee SCSCy 8 havent | Seromy nal, Sno ave [FORM FDA 483 (9/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERVATIONS Paget 12DEPARTMENT OF HEALTH AND HUMAN SERVICES. FOOD AND ORUG ADMINISTRATION SieRTSPPER CORFE Batmore Dart @LT-00) 000 eto ive ute Tot Satmere MO st2N8 rs (io) 7O048S _tabldnapetonacomespondencaMtia cox _| soetaseos 0: _DinoS.Muztn Sener Vee Present Mandactng Opertone 4 15901 East Lombard Strost - Vaccine Drug Substance Manufacturer Emergent Manufacturing Operations Baltimore, LC. ‘SIV, STATE AND 2 CODE - Baltimore, MO 21224 SDR SORENTO REPESENT Ai ACY Ux SME EARN OLR COMFLANC YO. Sucrawoudaronrancackae Poke ntact eu mL nsescnovo= TOUR WE CREED €. Personnel involved in manufacturing operations removed protective gowns and foot covers worn in ‘manufacturing Area and handling non-disinfected and non-decontaminated special medical waste from manufacturing Area in the warchouse with staged raw materials, failing to adhere to ‘owning procedures TThe following was directly observed during the inspection: £ Personnel involved with (BY and (YAY sampling operations were observed dragging raw material containers used in manufucturing Arca Macross the (®)I@) (B/N anc (YM) corridor, failing to adhere to materials and waste han procedures. | | Observation 8 Equipment used is not of adequate size to facilitate operations for its in maintenance inded use ot for cleaning and Specifically a. On 4/13/2021, J dating back to 2/22/2021 were observed in and on top of a plastic cont the| inside the microbiology laboratory that is used for testing of client/®@) viral dru substnee. These J included environmental monitoring Mf rave material (6) (4 and microbial limit testing for clien#8)@) that arc to be sent for microbial identification. This was overcrowded, and a cleanout had occurred on 4/12/2021 at room (IBD, was observed to be overcrowded. awaiting send out for identificatio retains for client 619 (BY(4) o@) ale ima and final drug substance samples, and laboratory supplies and needing storage under b, On4/14/202 Inside this| FORM FDA 483 (908) | saa 12M. Emorson Investigator 17D. Rickman, investigator ‘Jeremy Waly, Senior Advisor PREVIOUS Ebon OBSOLETE INSPECTIONAL OBSERVATIONS Patel| DEPARTMENT OF KEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION ee ‘DISTRICT OFFICE ADURESS AND PHONE WOWBER DATERIOF NSPECTION Baltimore Oistict (BLT-00) ‘ariz2021 ~ ar072021 | 6000 Metro Drive, Suite 101 | Balimore, MD 21215 FERONBER (410) 778.5455 ncetca nt 3015448605 Hite AND Tue OF NOWOUAL To WHOM REPORT Is ISSUED | To: Dino S. Muzzin, Senior Vice President Manufacturing Operations [rare ‘SREY ROORERS Emergent Manufacturing Operations Baltimore, LLC. ‘5901 East Lombard Steet TGHY. STATE AND 2 CODE FE GF ESTABCSFERT RSPEGTED — | Satimore, mo 21224 Vaccine Drug Substance Manufacturer TS DOSER USTs CRSEWATORS OER TE RET | REPRESENTA Fr AGENCY DETERUNATION REGAROING YOUR COMPARE. YOU AX CRIECT REGARDING A CBSERVATICN. | nor Consec we acon ese To OeRUniON YOU MA Dose CAE MO ACTOV Dn A | cect ra cricn Sorta A Tr AOORES ABOVE, TU MEANT GUSTIN AGE CONTAGT DAA THE POR MER Jou nemsrecron cr YER HE SERVED | Observation 9 | Equipment and/or utensils are not cleaned and maintained at appropriate intervals to prevent contamination | that would alter the safety, identity, strength, quality or purity of the drug substance | Specifically, a. The non-dedicated (6)(4) (EEE used to hold EE raw materials are not required by written procedure to be cleaned after each use. ‘The procedure as described in SOPOOISIS (version 14) requires that they are (B)(4)000 SEE with (6) whea travelling through the material airlock, b. L observed residue on the be of af inside the ArcafM@suite. Rouging was observed on the metal screws that coogi las in many ofthe fffeen inthe balay | Thess e used to transport material in Ares a = eee = ere Gobo ates PAGE Jeremy Wally FORM FDA 483 (9708), Pagel 12 PREVIOUS EDITION ee INSPECTIONAL OBSERVATIONS“The cbservations of objectionable conditions and practices isted ‘on the front of this form are reported: 41. Pursuant to Section 7040) 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 7O4(B) ef the Federal Food, Drug, and Cosmetic Ack 27 USC 374(b)) provides: "Upon compotion 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, operater, or agent in charge report in wrting setting forth eny 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 fithy, puted, or decomposed substance, ‘or (2) has been prepared, packed, or held under insantary conditions whereby it may have become contaminated wt fit, for whereby it may have been rendered injurious to health. A ‘copy of such report shall be sent promply to the Secretary."