946884

Pfizer Inc. — FEI 2416101

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 26, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
New York, NY (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
684221 CFR 314.80(j)Failure to maintain records