DEPARTMENT OF HEALTH AND HUrJiAN SERVICES 

FOOD AND DRUG ADMINISTRATION 

DISTRICT OF.FIGE ADDRE:SS AND PHONE NUMBER 

F:bA/CB'ERIOCSQ/DMPQ '.• 

l40l"Rockvflle Plke;·HF'M-67'() 

Ruck'viH~, MD :20&52 . ,'.f".frone: :Jof~8,27•3d3·1 ... · 

·~·@~str:y Ii!f'dt11~.tio'1t•.t>Xv,viftfa:g9,~1~~1fndust(y_ 

DATE(S) OF INSPECTION 

Jartuafy25 ._ 29, 2010 

FEINUMBER 

NAME AND T[TLE OF INDIVIDUAL.TO WHOM REPORT IS ISSUED 

'r5: l:Javit! Li.Ll1'd~l;S1\Vice Presitleht& Chief Scientific Officer 

STREET ADDRESS 

220 East Hanover Ave. 

CITY, STAT'E AND ZIP G:OOE 

Mo:rfis;Pfains,NJ 0'7"95d 

TYPE OF ESTABLISHMENT INSPECTED 

Celluhfr Therapy Prodt1ct Malmfacturing Facility 

TPJlS DdcOMENT LISTS'OBSER\/ATiONS MADE ,B'? THE.FDA REPRESENTATIVE{S) DURING THE INSPECTION OF YOUR FACILITY. THEY AFfE INSPECTIONAL 

'OBSERVAtrdNS:'Ai'l'O .DO Not REfiRESENt A Fi'NAl AGENCY DETERMINATION REGARDING YOUR COMPLIANCE. iF YOU HAVE AN OBJECTION REGARDING AN 

otrseRvAtroN; ·OR HA\jE 1MP:t_Elliiet-JtE'.b; .· M PlAf,rro 1MrLEMENT coRREcT1v1:: Act10N 1N. REsPo'NsE to AN oBsERVArroN, vou MAY Discuss. THE 

0BJEttr0N aiMct1oi'JiW1tH THEJDA REPRESENtATIVE{si ouR1NG THE 1NsPEcT10N oR suBM1t TH1s 1NFORMA1'10N To FDA AT THE ADDREss AsovE. IF 

YOU H/\\1E ANY Gl'UEStioNs, Pl.E:fl;SE C'ONTACT FD'AAT THE PHONE NUMBER AND ADDRESS ABOVE. 

dl:JRINGAi-ii'riJsPEtfr6Noi=YbuRFiRM{l)(WE) os·seRvEo:·· 

1. ; .. '.'. •;. )., ..:· ·:•: 'The .. .. . SOP.a11020: \Vorkstatibn Clearatite 

,. '• 

and 

' ,'• 

Change 

. ', 

Over 

" ' 

is deficient ,, ' ,' in 

,•,, 

that' it doe·s . 11ot require 

' ' 

QA 

iriVolveni.e11tfor verifying and:tele·asingthe wotkstatio11 after completion of the ptevious lotandprior W'in:itia:timi 

ofthe 

. . ' • 1 . ; . 

1rexl ldL 

2, EfiVi'i'6iJ~#~1JtaLm911.itori~1g .. tbl" conducted during the.iila.t1ufactuting processes is inadequate 

:inJhaHhe i'I . . . within the Class 

C1ei111·dl'>th,rrre·hot1n011ito1'ed thtbu'ghotH the e1~tire maim ac ut1ng pi'ocess. 

3. th~t~ttlteHrclea11itig p£ocedtJi"eS 'used in the cleai1l'l:>0til have 11ot bee1i qualified .

/s/

EMPLOYEE{S) NAME AND TITLE (Print or Type) 

•· c)ili1g Wang. l1h.[):. Biolbgisi (.Lea'd) · . · ••· .. :' .···' 

Rai1da Mellie.Iii, P.h.D., ~:.sc) ffetih:iii:I til.l1itt,i.qt/cs0 

Thm11ils Finil. Ph.D.. Microhiblti'gisi. ' 

Steven·Oh; Ph. ll. Mict(1bii1logisl, · .. 

DAT!;: ISSUED 

': ·, ' .· ..· . ·•·.· . JilliUal')i 29, 201 () 

FORM FDA.·4'83{! INSPl:CTIONAL OBSERVATION'S 
lhe 9b'servatibns of objectionable conditions and practices listed on the front of this form 

arereporte'd: , 

1. Plirstra'ntto Sedion 704(b) of the Federal Food, Drug and Cosmetic Act, or 

2; To ,,rssisffirms fnspeded in complying with the Acts and regulations enfotted by the 

Foo'd;and Qrug·Administration, 

s,e'cfi6n7Q4(b)t>ffhe . Peaeral Food, Drug, and Cosmetic Act (21 USC 374(b)) provides: 

. 

••.·..•. 11upan . compleHon of a'ny such inspection of a . facfoi\f,. warehouse, consuiting 

l~bbratofy; orotneitestsblishment, and prior to leaving the premises, the officer oremployee

making the irispecfion· .shall give to the owner, operator, or agent in Charge a report in 

writing setting forth any conditions or practices observed by him Which, in his judgement,

in'dic•afe thafany food,. drug, device, or cosmetic in such estab'lishment (1) consists in whole

i)f in part 

or 

of any filthy, putrid; or decomposed substance, or (2) has been prepared, packed, 

held under insanitary conditioM whereby it may have become contaYninated with filth; or

whereby it may have b'een rendered injurious to health. A c:opy of such report shall be sent

promptly to the serretai-y.'' 

FORM FDA' 483 '(9/08)