720399

Actavis Elizabeth LLC — FEI 2211563

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 26, 2011
Fiscal Year
2011
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Elizabeth, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
672821 CFR 314.80(b)Failure to review ADE information
673021 CFR 314.80(b)Failure to develop written procedures
673221 CFR 314.80(c)(1)(i)Late submission of 15-day report