Home / Inspections / 1125538

1125538

Bayer AG — FEI 3002806462

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 27, 2020
Fiscal Year
2020
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))
  • 1084360 (OAI Fri Mar 22 2019 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
162921 CFR 211.130(a)Prevention of cross contamination, mix-ups
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
430321 CFR 211.67(b)Written procedures fail to include
440221 CFR 211.192Written record of investigation incomplete