Drug factory · FDA FEI 2026154

Amgen, Inc

One Amgen Center Drive, Thousand Oaks, CA, United States

What it does, for whom

FDA inspection history

What inspectors wrote down

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Mar 13, 2025 inspection

• Procedures for sterile drug products 21 CFR 211.113(b)
  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
• Acceptance of in-process materials 21 CFR 211.160(b)(2)
  Determinations of conformance to appropriate written specifications for acceptance are deficient for in-process materials.
• No written record of investigation 21 CFR 211.192
  Written records are not made of investigations into unexplained discrepancies.
• Systems in place to comply with verification requirements FDCA 582(b)(4)
  Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.

Dec 13, 2019 inspection

• Cleaning SOP/inspection 21 CFR 211.67(b)(6)
  Procedures for the cleaning and maintenance of equipment are deficient regarding inspection of the equipment for cleanliness immediately before use.

Dec 12, 2012 inspection

• Failure to develop written procedures 21 CFR 314.80(b)
  Written procedures have not been developed for the surveillance and receipt of post marketing adverse drug experiences.
• Failure by applicant to report ADE 21 CFR 314.80(c)
  Adverse drug experience information has not been reported to FDA.
• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
• Failure to report post-marketing study ADEs 21 CFR 314.80(e)
  Fifteen-day Alert reports have not been submitted for all adverse drug experiences during post marketing studies, where there was a reasonable possibility that the drug caused the adverse experience.
• Review of Adverse Experiences - SOPs 21 CFR 600.80(b)
  There are no written procedures for the surveillance, receipt, evaluation, and reporting of post-marketing adverse experiences to FDA.
• Reporting Requirements 21 CFR 600.80(c)
  Adverse experience information was not reported to FDA as required.
• Reporting Requirements - 15-day alert 21 CFR 600.80(c)(1)(i)
  All serious and unexpected adverse experiences were not reported within 15 calendar day of initial receipt of the information.
• Reporting Requirements - 15-day alert follow up 21 CFR 600.80(c)(1)(ii)
  Regarding the follow up of serious and unexpected adverse experiences, follow-up reports containing new information were not submitted in the appropriate time frames.

Jun 3, 2010 inspection

• Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
  Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.

Registered with FDA for: analysis; api manufacture; label; manufacture; pack.