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1178420

Bayer HealthCare, LLC — FEI 2910913

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 26, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Berkeley, CA (United States)

Facility

Other inspections at this facility

  • 1250181 (NAI Wed Oct 30 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111955 (VAI Thu Nov 21 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1068508 (VAI Fri Sep 21 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 995350 (VAI Tue Dec 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 849656 (VAI Thu Sep 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
116221 CFR 211.28(a)Protective Apparel Not Worn
121521 CFR 211.67(b)Written procedures not established/followed
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified