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--------------------middot ----middot- middot-middot------DEPARTMeNT OF HEALTH ANO HUMAN sfRVJCfS
FOOD AND DRUG AOMINISTRATION
tfJ=---7~__-~ --------
Intlllnational Complilmcc Team OMIQOCCDEN fDA White Oak Buiding 51 4111 Floor middot
IST~ICT OFFICE f ANIJ PHONE NUMBER OATE(S) OF INSIgtECTION middotmiddot -middot Feb 20 21 22 211 amp 26 2Q08 FEINUMBER
10904 New HIUilpshire Avenue ) Silver Spring MD 20993 lJSA ( ~0 I ~
iIIMe AND nTLii OF INOIYIOUAL TO WHOM REPORT lS SSUO
middotTO Mr Van-wang General Manager i=iRMNAME S
Changzhou S~L Company Ltd TREET ADDRESS
3 Changhong West Road -------+-=rvigtE ciiEsTAiiiisHMENTINsPEcrIW-------------
Wujln Charigzhou City Jiangsu Province China API (animal origin) ManufacIU11W THIS UloiENT ~ISTS OSSERVAnONs BY THE FOA REPRESENTATJVe(S)IlliRj~ TNE 1NSPECf0tiOFYOUR FACILfTV Tkpoundl ARE INSPiiCTIUgtIAI OB$ERVATiONS ANOOO NOT REPRESENT A FINAL AGENCY OEmRMNAllOH REGARDING YOUR COMPliANCE IF YOU HAVE AN OAJECYIONMGARDING AN OIISERVATONOR HAVE 1111LEWNTEOOR PLAN TO IMPlEIIiNt CORRECTIVE ACllON IN RESPONSE TO AN oeiERVATi()ltl YOJ MAY DISCUSS THE DBETION OR ACTION WITH THF ~ REPRESENTATIIIE(S) DURING THE INSPECTWN OR SU8MI1 THIS IN~ORPMTION TO FDA AT THE ~S ABOYE If VOU HAVI ANY IJOOiTIONS PLEASE CONTACT FDA AT THE PHONE NJMBSR AND ADDRESS ABOVE
OURJNO AN INSPECrt(JN or- YOlR FIRihro OOSER~ED [ - I L Thtlre have been no critical processing steps identiticd fur the Heparin Sodium USP _ Jpnxc~s 1111~ the repeated and tificioot removal ofimpuritill8 such u proteins nuclcotides vhu~ endotoxin_bilcteria and healy meuus at the applopriate spc~ified prltlCess steps has not been evaluated There was uo report for annual[ sl nsullaquo~anilable
]ll~Jm~rQY~~cnts oftered by ~Jmiddot oval o~rltJwJEria_ tf-middot~_~=J~~l_I~~ --~middot_]it~lt~ize r tht anar 1and increase sn addedmiddot
step a chaose in middot fur step panunctcr changess-ppwved iJl 105 process va i ion report for eparin So3ium USP wsre not demonstrated 1 shy
Th~re has been no impurity profile established for Hep~n Sodium USP aJ)d no cvaiUBtion fiJr dcgradants during stability prog2
ram testing
3 The manufocturinyinstructiQ_lS for Heparin Sodium USP are incomplete in that thr-y do not include a dlllltrll__-_ tQIlQf munual manipulations ofthl ]during proctsling steps they do not include the actulll manualy middotentered[ _ ] poundet tvmperlrtures and times 1111doperator obsetv11tions ~uch as Jevel mCliSunmcnts used _in calculations during the_ ] step atmiddote not recorded
4 There hasbee11 uo Lest mllthod velification performed f)r the rcportld USP USt method5 Nitrogen Detennimuiun_Protllin and Tolal Aerobic Microbial Count bull employed ln testing oHiepnrin Sodium USP 1tnd Heparin middotCru4~~1erials 10 show that the methods are suiwhle under actual conditions ofuse Ju Wdition there is no routine test ro Jmiddot~idue amount at the tin1c middot ofrelease middot middot middot middot middot
S Investigations into failed lots and out of trend lots were approved as complete but did not identitY a e~~us~ for the problem For ~xample middot
Heparin_ ~odium USP batch[ - - -middot ] fuiled the Nitrogen DetermiJlation test and wa11 reprocessed to milk~ [ - J withuut ti~ding the reasa~he sli_gh~~~~~h -~S Nitroge~ resul~ - ~ __
_l~~~gationR in sWtnuto~co [ i~pec_if1cation [ lror Heparin Sodiwn USP ICits J Fltrflit wl~t mw=r~~=-~ 2~~7 ~j~ blaquoh -
1nappropnately_as uutllers bull middot------ ------- - shy
~-~-~in_Cruj ~~~~~~~~a~i-~1 ~o~ 0~~~ -~~~~~~rfrOv~~in ~~arinSodium US~ _J mark~cdJo the ~SA Jn addttiOll pnor to 306 there aru noL ] records from vendor[
J showmg the source for the~r crude rnnterlnJs middot shy
~middotTJNj~4~~~~~~~o~~~hJ~~~k~i-~ middotd~~ni~1t~~~~~-~~ld middot~-middot ~~~J~~d~~~i~0~Jtich SPIlledt~e bouom of the hmk when~~ was uprighted Tha-e was no writtr-rt procedun ~hltlwing th1tt the tanks were dedicurud to A part1cular process step There WIIS no dat11 collect~ to ve~ity m11rlwr and tape volume mntkin~s on the ou~ide of the link-
EE E7LOYEE(S) SIG~TRE =rnEMPLOIce($) NAME ANO TITLE (PiiniDr Type DATe ISSUED VERSE D- rA ~ )
-~---
RE T B I QF THIS g na - rown nvt gator Fampb H 2008
PAGE ZI-Qiang Gu Chllmlst
FORM FDA -83 (4103) PRE US EDITION OB OLI~TE (rsc lmiddot ~~) INSPECTIONAL OBSERVATIONS- PAGE 1 of 2 PAGES bull
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND D~UG AOMINISTRATION
---------- middot middot~------0-A-TE(S-)-0-FIWNIP=EC~n~()N=----shy
Wujlng Chan~hoo City Jlangau Prolllnce China API (animal origin) Manufacturer
FEINUMBER International Complinnce Team DMPQOCCPER fDA White Oak ~uiding 51 4o Floor 10903 New Hampshire Avenue SiLver Spring MD 20993 USA __________ -------1
=E-AN~D TITLE OF INOMDUAL TO WHOMREiiPO=RT-=ISIs=s-UED---------------- shy1-Nc-AM
--------------------------------------------------------
DISTRICT OFFICE JIOORESS AND PHONE NUMIIEii feb 20 21 22 25 amp 26 2008
TO Mr Y11n WangmiddotGaneral Yanagbullr ----------rsTREET-AODREcSS-----~-------------------- middotmiddotmiddot-------i FIRM NM
Ch~ngzhou SPL Company Ltd 3 Changhong Wet Road CITV STIITE AND ZIP cooemiddot--------- --------------trvfieoi esiAiiilsHMENTINsPecno--------~------i
THIS OOCUMENT uiifs OBSERIATIONS tMOpound BY THE FDA REPRESENTATIVEtS) DURING THE INSPECTION OFVOUI FACIUTY THfY AI1E tiSPECTIONAi OBSERVAlIONSAND DO NOT REPREqiNT AFIHAL AGENCY DETERMINATION RE(~ROING YOUR COMPUANCI IF YOO HAVE AN OBJECTION REGAAOINO AN OBSERVATION OR HAIE 1API ~MENTEO OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN tlBS~RVATION YOJ MAY DISCUSS THE OIIJ~CllON OR ACTION WITli THE FOil REPRESENTATIVE(S) DURING THE INSPFCTION OR SUBMIT THIS INFORMATION TO fDA ATJ1E A(lDRESS IlBOVpound if YOU HAVE AN OllESllONS PlEASE CONTACT FDA AfTHE PHONE NUMIIIR ANU ADDRESS ABOVE
llJR1NIJ AN INSPECTION OF YOUR ARII OIISEIIVal nod the cleaning method WitS not validated lL was noted that equipment cleuninamp tags were made ofpaper and taped o the piece of equipment uupro~Lcxl from liquids used in the processing room environments
8 Raw material inventory records were inoomplcte in that samples removed from lh contai~i Mdthe status and nmount of materials rewmed from UJC by the production proces1gting departmem were not recorded For L J stored in a frecwr the amount condition nnd date of return was not recorded
9 Control of rnaterial flow in Lhc processing area WftS inwiequate in that wamf ]wRS carted through a door to the outside in the plOCe~sing alea and nut provided for by tht material tJow wriuen procedlrfe
10 The outer foil bags containing Hparin Sodium U~P lot [ __ _________l_manufactured IUld hcld raquoincc 52507 are not laHled
The drum lid snowed the only indications of the lot number --middot
11 There is no report ltlr data w ~how that leachablcS for thec --middot--middot- middot--l hags used to hold Heparin Sodium lTSl lot have boon evulullted ~
~-~~fSE OI THIS
PAGE middot
TEMPLOY~T~$~- middot IDATEISSUEO middot shy
EMPLOYEE(S)HAMEANDTiTLEPrlnlorTypeJ _I _- Regina T Brownlnveotigator
Zl-Ciang Gu Chornillt t( L ~ A_ ( RM FDA 483 (AOJ) FO PRE -OEltSOLETE V O~ocT ON tr- ~ gtltmiddot ICIJO li~J INSPECTION-A~L-=Oas==ERVA-T=I~ONS~--ffgt-AG=E-2-o1I I -2
Fllb 28 2008
pAGE$
Zd L0 cc B00Z 9G middotqa~ ON XtH WOCl
The observations of objectionable conditions and practices listed on the front of this form are reported
1 middotpursuant to Section 704(b) 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 704(b) of the Federal Food Drug and cosmetic Act (21 USC 374(b)) provides
Upon completion 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 operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgment Indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under unsanitary conditions whereby it may have becorrte contaminated with fith or whereby it may have been rendered injurious to health A eopy of sueh report shell be sent promptly to the Secretary
fORM fDA 483 (4aS)
WO~ON Xt[d
DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND D~UG AOMINISTRATION
---------- middot middot~------0-A-TE(S-)-0-FIWNIP=EC~n~()N=----shy
Wujlng Chan~hoo City Jlangau Prolllnce China API (animal origin) Manufacturer
FEINUMBER International Complinnce Team DMPQOCCPER fDA White Oak ~uiding 51 4o Floor 10903 New Hampshire Avenue SiLver Spring MD 20993 USA __________ -------1
=E-AN~D TITLE OF INOMDUAL TO WHOMREiiPO=RT-=ISIs=s-UED---------------- shy1-Nc-AM
--------------------------------------------------------
DISTRICT OFFICE JIOORESS AND PHONE NUMIIEii feb 20 21 22 25 amp 26 2008
TO Mr Y11n WangmiddotGaneral Yanagbullr ----------rsTREET-AODREcSS-----~-------------------- middotmiddotmiddot-------i FIRM NM
Ch~ngzhou SPL Company Ltd 3 Changhong Wet Road CITV STIITE AND ZIP cooemiddot--------- --------------trvfieoi esiAiiilsHMENTINsPecno--------~------i
THIS OOCUMENT uiifs OBSERIATIONS tMOpound BY THE FDA REPRESENTATIVEtS) DURING THE INSPECTION OFVOUI FACIUTY THfY AI1E tiSPECTIONAi OBSERVAlIONSAND DO NOT REPREqiNT AFIHAL AGENCY DETERMINATION RE(~ROING YOUR COMPUANCI IF YOO HAVE AN OBJECTION REGAAOINO AN OBSERVATION OR HAIE 1API ~MENTEO OR PLAN TO IMPLEMENT CORRECTIVE ACTION IN RESPONSE TO AN tlBS~RVATION YOJ MAY DISCUSS THE OIIJ~CllON OR ACTION WITli THE FOil REPRESENTATIVE(S) DURING THE INSPFCTION OR SUBMIT THIS INFORMATION TO fDA ATJ1E A(lDRESS IlBOVpound if YOU HAVE AN OllESllONS PlEASE CONTACT FDA AfTHE PHONE NUMIIIR ANU ADDRESS ABOVE
llJR1NIJ AN INSPECTION OF YOUR ARII OIISEIIVal nod the cleaning method WitS not validated lL was noted that equipment cleuninamp tags were made ofpaper and taped o the piece of equipment uupro~Lcxl from liquids used in the processing room environments
8 Raw material inventory records were inoomplcte in that samples removed from lh contai~i Mdthe status and nmount of materials rewmed from UJC by the production proces1gting departmem were not recorded For L J stored in a frecwr the amount condition nnd date of return was not recorded
9 Control of rnaterial flow in Lhc processing area WftS inwiequate in that wamf ]wRS carted through a door to the outside in the plOCe~sing alea and nut provided for by tht material tJow wriuen procedlrfe
10 The outer foil bags containing Hparin Sodium U~P lot [ __ _________l_manufactured IUld hcld raquoincc 52507 are not laHled
The drum lid snowed the only indications of the lot number --middot
11 There is no report ltlr data w ~how that leachablcS for thec --middot--middot- middot--l hags used to hold Heparin Sodium lTSl lot have boon evulullted ~
~-~~fSE OI THIS
PAGE middot
TEMPLOY~T~$~- middot IDATEISSUEO middot shy
EMPLOYEE(S)HAMEANDTiTLEPrlnlorTypeJ _I _- Regina T Brownlnveotigator
Zl-Ciang Gu Chornillt t( L ~ A_ ( RM FDA 483 (AOJ) FO PRE -OEltSOLETE V O~ocT ON tr- ~ gtltmiddot ICIJO li~J INSPECTION-A~L-=Oas==ERVA-T=I~ONS~--ffgt-AG=E-2-o1I I -2
Fllb 28 2008
pAGE$
Zd L0 cc B00Z 9G middotqa~ ON XtH WOCl
The observations of objectionable conditions and practices listed on the front of this form are reported
1 middotpursuant to Section 704(b) 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 704(b) of the Federal Food Drug and cosmetic Act (21 USC 374(b)) provides
Upon completion 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 operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgment Indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under unsanitary conditions whereby it may have becorrte contaminated with fith or whereby it may have been rendered injurious to health A eopy of sueh report shell be sent promptly to the Secretary
fORM fDA 483 (4aS)
WO~ON Xt[d
The observations of objectionable conditions and practices listed on the front of this form are reported
1 middotpursuant to Section 704(b) 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 704(b) of the Federal Food Drug and cosmetic Act (21 USC 374(b)) provides
Upon completion 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 operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgment Indicate that any food drug device or cosmetic in such establishment (1) consists in whole or in part of any filthy putrid or decomposed substance or (2) has been prepared packed or held under unsanitary conditions whereby it may have becorrte contaminated with fith or whereby it may have been rendered injurious to health A eopy of sueh report shell be sent promptly to the Secretary
fORM fDA 483 (4aS)
WO~ON Xt[d
