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1256132

Amgen, Inc. — FEI 2026154

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
March 13, 2025
Fiscal Year
2025
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Thousand Oaks, CA (United States)

Facility

Other inspections at this facility

  • 1278976 (NAI Thu Aug 07 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1220409 (NAI Thu Sep 14 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1112791 (VAI Fri Dec 13 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1028320 (NAI Mon Aug 21 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1014825 (NAI Wed Apr 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
145121 CFR 211.113(b)Procedures for sterile drug products
22921FDCA 582(b)(4)Systems in place to comply with verification requirements
360721 CFR 211.160(b)(2)Acceptance of in-process materials
457621 CFR 211.192No written record of investigation