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831617

Bayer HealthCare, LLC — FEI 2910913

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 24, 2013
Fiscal Year
2013
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))
  • 1178420 (VAI Fri Aug 26 2022 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))

Citations

IDCFRDescription
126321 CFR 211.68(b)Computer control of master formula records
145121 CFR 211.113(b)Procedures for sterile drug products
189021 CFR 211.165(e)Test methods
202721 CFR 211.192Investigations of discrepancies, failures