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955347

Fareva Mirabel — FEI 1000173162

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 19, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Riom (France)

Facility

Other inspections at this facility

  • 1271381 (VAI Fri Jul 22 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124081 (VAI Fri Mar 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054784 (VAI Fri Jun 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 885746 (VAI Thu May 22 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 732459 (VAI Mon May 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
145121 CFR 211.113(b)Procedures for sterile drug products
145221 CFR 211.113(b)Validation lacking for sterile drug products
241921 CFR 211.198(a)Complaint Handling Procedure
430221 CFR 211.56(b)Written sanitation procedures not followed
891121 CFR 314.81(b)(1)(ii)Failure to meet specifications