988466

Merck & Co Inc — FEI 3002721810

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 20, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
North Wales, PA (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

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