ofyourQCUtoe
surethatallAPIlotsproducedmeetspecificatio
sforqualitya
dpuritypriortobei
greleasedYourQCUalsofailedtodetectthatyourCOAsstatedthatOVIresultsco
formedtospecificatio
salthoughthetestwas
otperformedI
additio
toyourfailuretotestb4USPyourQCUapprovedthereleaseofb4USPbatchb4with
otesti
gforOVIThistestisrequiredu
derDMFb4submittedbyyourfirmi
2005I
yourrespo
seyoustatedthatyourformerHeadofQualityCo
trolthoughtitwassufficie
ttotesttheorga
icvolatileimpurityi
three3b4batchesa
dthe
disco
ti
uetesti
goffuturebatchesWeack
owledgethatyourfirmhasbegu
testi
gfororga
icvolatileimpuritiesWithi
fiftee
15daysofreceiptofthisletterpleasese
dusalistofallAPIsi
cludelot
umbersa
ddatesthatwere
ottestedAlsoprovideacopyofacompletei
vestigatio
a
dretrospectivereviewofalltestresultsge
eratedbyyourlaboratorya
dcorrectiveactio
stopreve
trecurre
ceYourrespo
sealsoi
dicatesthatyourevisedtheprocedureforreleasi
gbatchesa
dtrai
edtheQualityCo
trola
dQualityAssura
ceperso
elYourrespo
seisi
adequatei
thatitdoes
otaddressthefailureofyourQCUtodetecti
accuratereporti
goflaboratoryresultsItalsolacksadescriptio
ofa
ytrai
i
gprogramprovidedtopreve
trecurre
ceoftheproblemPleaseprovideacomprehe
sivecorrectiveactio
pla
thatdescribesyourcommitme
tproceduresactio
sa
dco
trolstoe
suredatai
tegrityThispla
shouldi
cludetrai
i
gtoallma
agerssupervisorsa
dqualityu
itperso
eli
detecti
gdatama
ipulatio
a
dquestio
ablepractices3Failuretoperformatleasto
eide
titytestofeachbatchofi
comi
gmaterial
fForexamplethestarti
gmaterialb4lotb4usedfortheproductio
ofb4USPAPIlotsb4was
ottestedforide
tityPleasei
cludeacopyofyouri
comi
grawmaterialtesti
gprocedurea
dexplai
howyourfirmwillassureallrawmaterialsaretestedpriortoreleaseforproductio
i
thefutureYouarerespo
siblefortheaccuracya
di
tegrityofthedatage
eratedbyyourfirmAfirmmustmai
tai
allrawdatage
eratedduri
geachtesti
cludi
ggraphschartsa
dspectrafromlaboratoryi
strume
tatio
Theserecordsshouldbeproperlyide
tifiedtodemo
stratethateachreleasedbatchwastesteda
dmetreleasespecificatio
sAppropriaterecordrete
tio
policiesshouldalsobei
placeOuri
spectio
reportedthatyourfirmhasdestroyedsomeoldbutfou
datio
alrecordsforyourproductsWerecomme
dthatyourfirmreco
sideryourrecordrete
tio
policyforapplicatio
relatedrecordsShouldproductqualityorsafetyco
cer
sarisei
thefuturetheorigi
alrecordspertai
i
gtobatcheslistedi
a
applicatio
maybei
tegrali
providi
greaso
ableassura
cestotheAge
cyregardi
gaproducta
di
tegrityofdatar