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889209

Bayer AG — FEI 3002808086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 13, 2014
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Berlin (Germany)

Facility

Other inspections at this facility

  • 1282736 (VAI Thu Jun 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1239178 (VAI Fri Aug 27 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1102816 (VAI Tue Sep 24 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1001127 (NAI Tue Jan 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876478 (NAI Thu Apr 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
202821 CFR 211.192Extent of discrepancy, failure investigations
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete