美国FDA给予药企的警告信(含中文翻译).pdfVIP

WARNINGLETTER

CMS535005

December19,2017

VIAUPSNEXTDAYAIR

PaulF.Devine,CEO/President

C.O.Truxton,Inc.

136HardingAvenue

Bellmawr,NJ08031

DearMr.Devine:

TheU.S.FoodandDrugAdministration(FDA)inspectedyourdrugmanufacturing

facility,C.O.Truxton,Inc.(“Truxton”),at136HardingAvenue,Bellmawr,New

Jersey(FEI2220338),fromApril17toJune1,2017.

Thiswarninglettersummarizessignificantviolationsofcurrentgoodmanufacturing

practices(CGMP)regulationsforfinishedpharmaceuticals.See21CFR,parts210

and211.

Becauseyourmethods,facilitiesorcontrolsformanufacturing,processing,packing,

orholdingdonotconformtoCGMP,yourdrugproductsareadulteratedwithinthe

meaningofsection501(a)(2)(B)oftheFederalFood,Drug,andCosmeticAct(FDC

Act),21U.S.C.351(a)(2)(B).

Inaddition,yourfirmmislabeleddrugproducts,causingthemtobemisbrandedunder

section502(b)(2)and502(e)(1)(A)(ii)oftheFDCAct,21U.S.C.352(b)(2)and

21U.S.C.352(e)(1)(A)(ii).Byintroducingadulteratedandmisbrandeddrugsinto

interstatecommerceyouareinviolationofsection301(a)oftheFDCAct,21U.S.C.

331(a).

WereviewedyourJune14,2017,responseindetail.

Duringourinspection,ourinvestigatorobservedspecificviolationsincluding,but

notlimitedto,thefollowing.

CGMPViolations

1.Yourfirmfailedtoestablishaqualitycontrolunitwiththe

responsibilityandauthoritytoapproveorrejectallcomponents,drugproduct

containers,closures,in-processmaterials,packagingmaterials,labeling,and

drugproducts(21CFR211.22(a)).

Yourfirmfailedtoestablishaqualitycontrolunitforyourdrugrepackaging

operationandyoulackedwrittenproceduresforproductionorqua