FDA Inspection
Amgen, Inc.Amgen, Inc. – FDA Inspection, Mar 13, 2025
Record Details
This FDA Inspection record concerns Amgen, Inc., with an inspection on March 13, 2025, issued by the Los Angeles District Office, covering human drugs.
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ID · 8601b5a4-a27d-4f90-9399-1e0398db8be7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1256132
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
4- 21 CFR 211.160(b)(2)Acceptance of in-process materials
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192No written record of investigation
- FDCA 582(b)(4)Systems in place to comply with verification requirements
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Other FDA inspections of Amgen, Inc.
29| Date | Classification | Office | Project area |
|---|---|---|---|
| August 7, 2025 | Not classified | Los Angeles District Office | |
| 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 |
| March 16, 2018 | Not classified | Los Angeles District Office |
Other documents for Amgen, Inc.
- FDA Inspection 1278976 - 2025-08-07
- FDA Inspection 1240449 - 2024-02-06
- FDA Inspection 1220409 - 2023-09-14
- FDA Inspection 1112791 - 2019-12-13
- FDA Inspection 1046609 - 2018-03-16
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