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1061201

Amgen Manufacturing Limited LLC — FEI 1000110364

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 6, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Juncos, PR (United States)

Facility

Other inspections at this facility

  • 1209484 (VAI Wed Jul 05 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1085900 (VAI Thu Apr 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1016325 (VAI Wed May 10 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 913643 (VAI Wed Feb 11 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912248 (VAI Fri Jan 23 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete