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1084360

Bayer AG — FEI 3002806462

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
March 22, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Leverkusen (Germany)

Facility

Other inspections at this facility

  • 1247034 (VAI Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1209999 (NAI Fri May 13 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1125538 (VAI Mon Jul 27 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004195 (OAI Fri Jan 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 975815 (NAI Fri Jun 03 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
150421 CFR 211.122(d)Labels and labeling stored separately
180921 CFR 211.160(a)Following/documenting laboratory controls
200921 CFR 211.188Prepared for each batch, include complete information
358221 CFR 211.105(a)Identification of containers, lines, equipment
358521 CFR 211.110(a)Control procedures to monitor and validate performance
430321 CFR 211.67(b)Written procedures fail to include