645466

Teva Pharmaceuticals USA, Inc — FEI 3003092769

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 1, 2010
Fiscal Year
2010
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Parsippany, NJ (United States)

Citations

IDCFRDescription
241921 CFR 211.198(a)Complaint Handling Procedure
256721 CFR 211.198(a)Adverse Drug Experience
358521 CFR 211.110(a)Control procedures to monitor and validate performance
890821 CFR 314.81(b)(2)(i)Summary
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications