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967375

Bayer Bitterfeld GmbH — FEI 3003882513

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 8, 2016
Fiscal Year
2016
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Bitterfeld-Wolfen (Germany)

Facility

Other inspections at this facility

  • 1272339 (VAI Wed Jun 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1124409 (NAI Wed Jul 10 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1048506 (VAI Fri Mar 23 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 887887 (VAI Fri Dec 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
125621 CFR 211.68(b)Backup file not maintained
180921 CFR 211.160(a)Following/documenting laboratory controls
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
434221 CFR 211.142(b)Storage under appropriate conditions
437521 CFR 211.188(b)(5)In-process and laboratory control results