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1102816

Bayer AG — FEI 3002808086

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
September 24, 2019
Fiscal Year
2019
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))
  • 1001127 (NAI Tue Jan 24 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 889209 (VAI Tue May 13 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876478 (NAI Thu Apr 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121521 CFR 211.67(b)Written procedures not established/followed
143521 CFR 211.42(c)(10)(v)Cleaning System
182321 CFR 211.84(c)(4)Top/Middle/Bottom container sampling