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FDA Inspection 1268935 — Opella Healthcare International SAS

Opella Healthcare International SAS — FEI 3003492806

The FDA completed an inspection of Opella Healthcare International SAS on January 10, 2025 in Compiegne. 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
January 10, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Compiegne (France)

Additional Details

Mutual Recognition Agreement (MRA)

Facility

Other inspections at this facility

  • 1123990 (VAI Thu Oct 31 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1015497 (VAI Fri Jun 23 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 946883 (VAI Fri Sep 18 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 853427 (VAI Thu Sep 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 754638 (NAI Fri Oct 21 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

FDA data resources