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946883

Opella Healthcare International SAS — FEI 3003492806

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 18, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Compiegne (France)

Facility

Other inspections at this facility

  • 1268935 (VAI Fri Jan 10 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))
  • 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))

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
241921 CFR 211.198(a)Complaint Handling Procedure
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products