Amgen, Inc. – FDA Inspection, Dec 12, 2012

Record Details

This FDA Inspection record concerns Amgen, Inc., with an inspection on December 12, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company: Amgen, Inc.
Inspection Date: December 12, 2012
Product Type: Drugs
Office: Center for Drug Evaluation and Research

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ID · 41d53a38-6e2b-4a9b-8015-332a24ba634c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 810409
FDA center: Human Drugs
Project area: Bioresearch Monitoring

FDA Citations

21 CFR 314.80(c)Failure by applicant to report ADE
21 CFR 600.80(c)Reporting Requirements
21 CFR 600.80(c)(1)(i)Reporting Requirements - 15-day alert
21 CFR 314.80(e)Failure to report post-marketing study ADEs
21 CFR 314.80(c)(1)(i)Late submission of 15-day report
21 CFR 600.80(c)(1)(ii)Reporting Requirements - 15-day alert follow up
21 CFR 600.80(b)Review of Adverse Experiences - SOPs
21 CFR 314.80(b)Failure to develop written procedures

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Other FDA inspections of Amgen, Inc.

Date	Classification	Office	Project area
August 7, 2025	Not classified	Los Angeles District Office
March 13, 2025	VAI	Los Angeles District Office	Drug Quality Assurance
February 6, 2024	Not classified	Los Angeles District Office
September 14, 2023	NAI	Center for Drug Evaluation and Research	Bioresearch Monitoring
December 13, 2019	VAI	Center for Drug Evaluation and Research	Drug Quality Assurance