FDA Inspection 1001769 — CMP Pharma Inc

CMP Pharma Inc — FEI 1050589

The FDA completed an inspection of CMP Pharma Inc on December 21, 2016 in Farmville, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 21, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Farmville, NC (United States)

Additional Details

Postmarket Adverse Drug Experience (PADE)

Citations

IDCFRDescription
673021 CFR 314.80(b)Failure to develop written procedures
682921 CFR 314.80(c)(2)Failure to report non-alert ADEs