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1015497

Opella Healthcare International SAS — FEI 3003492806

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 23, 2017
Fiscal Year
2017
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))
  • 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))

Citations

IDCFRDescription
111121 CFR 211.25(a)Training , Education , Experience overall
117721 CFR 211.63Equipment Design, Size and Location
145021 CFR 211.113(a)Procedures for non-sterile drug products
240121 CFR 211.194(a)(4)Complete Test Data