1019314

Amerigen Pharmaceuticals Inc. — FEI 3008849302

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Lyndhurst, NJ (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures