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1220500

Biogen U.S. Corporation — FEI 3010164829

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 17, 2023
Fiscal Year
2024
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Durham, NC (United States)

Facility

Other inspections at this facility

  • 1178753 (VAI Fri Aug 26 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 951256 (VAI Thu Dec 10 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922850 (NAI Thu Apr 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
438921 CFR 211.198(a)Procedures to be written and followed