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1001769

CMP Pharma Inc — FEI 1050589

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)

Facility

Other inspections at this facility

  • 1217480 (VAI Fri Sep 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1196186 (NAI Wed Jan 25 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1061287 (VAI Thu Jun 28 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023838 (NAI Thu May 25 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 978929 (VAI Wed May 11 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

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