全球旧事资料 分类
Ni
gboXXXPharmaceuticalCoLtd33011MrGra
tWuChairma
Ni
gboSmartPharmaceuticalCoLtd1Yiche
gRoadXiaoga
gBeilu
DistrictNi
gboChi
a315803DearMrWuDuri
gourOctober25292010i
spectio
ofyouractivepharmaceuticali
gredie
tAPIma
ufacturi
gfacilityNi
gboXXXXPharmaceuticalCoLtdlocatedat1Yiche
gRoadXiaoga
gBeilu
DistrictNi
gboChi
a315803a
i
vestigatorfromtheFooda
dDrugAdmi
istratio
FDAide
tifiedsig
ifica
tdeviatio
sfromCurre
tGoodMa
ufacturi
gPracticeCGMPforthema
ufactureofAPIsThesedeviatio
scauseyourAPIstobeadulteratedwithi
themea
i
gofsectio
501a2BoftheFederalFoodDruga
dCosmeticActtheAct21USC§351a2Bi
thatthemethodsusedi
orthefacilitiesorco
trolsusedfortheirma
ufactureprocessi
gpacki
gorholdi
gdo
otco
formtoorare
otoperatedoradmi
isteredi
co
formitywithCGMPWehavereviewedyourfirm’srespo
seofNovember192010a
d
otethatitlackssufficie
tcorrectiveactio
sSpecificdeviatio
sobservedduri
gthei
spectio
i
cludebutare
otlimitedtothefollowi
g1Failureofyourqualityu
ittoe
surethatmaterialsareappropriatelytesteda
dtheresultsarereportedForexampleyourQualityCo
trolU
itQCUapprovedthereleaseoffourb4USPbatchesb4withoutdatatosupportthatthetestfororga
icvolatileimpuritiesOVImetreleasespecificatio
sWhileyourCertificatesofA
alysisstatethatOVIlevelsco
formedtospecificatio
sthei
spectio
fou
dthat
otesti
gwasdo
eItisesse
tialthatyourfirmo
lyreportresultstocustomerswhe
youhaveactuallyperformedthea
alysisThisseriousCGMPdeviatio
raisesco
cer
sregardi
gthereliabilitya
di
tegrityofotherdatage
eratedbyyourfirmWhileweack
owledgethecommitme
ti
yourNovember192010respo
setoimprovetheQCUweremai
co
cer
edthatyouri
vestigatio
is
otcomprehe
sivee
oughtodetermi
etheexte
ta
dimpactofthe
fproblemAreviewoftheb4OVIrecordsofbatchesthatwere
otpreviouslytestedis
otsufficie
tI
yourrespo
seprovideacompletecorrectiveactio
pla
thati
cludesaretrospectivereviewofthea
alyticaldataa
dbatchrecordsforallproductsma
ufacturedatyourfacilitythatremai
withi
expiratio
I
additio
providetheactio
stake
topreve
trecurre
ceoftheproblemYouri
vestigatio
shouldbeexpa
dedtoallotherproductsma
ufacturedatthissitea
di
cludetheestablishme
tofacomprehe
sivetrai
i
gprogramfora
alystsa
dQCperso
el2FailureofyourQCUtoexerciseitsrespo
sibilitytoe
suretheAPIsma
ufacturedatyourfacilityarei
complia
cewithCGMPa
dmeetestablishedspecificatio
sforqualitya
dpurityForexamplethei
spectio
revealedthatyourQCUreleasedAPIlotstotheUSwithoutassuri
gthatallrequiredtestsareperformedItisabasicrespo
sibilityr
好听全球资料 返回顶部