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FDA Inspection 1206214 — Amphastar France Pharmaceuticals

Amphastar France Pharmaceuticals — FEI 3003672088

The FDA completed an inspection of Amphastar France Pharmaceuticals on November 25, 2022 in Eragny Sur Epte. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 25, 2022
Fiscal Year
2023
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Eragny Sur Epte (France)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1061143 (VAI Fri Jun 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 964572 (VAI Fri Mar 04 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 822994 (VAI Thu Feb 07 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 665559 (VAI Tue Mar 23 2010 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 625848 (NAI Tue Oct 20 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources