FDA Inspection
Amgen, Inc.Amgen, Inc. – FDA Inspection, Dec 13, 2019
Record Details
This FDA Inspection record concerns Amgen, Inc., with an inspection on December 13, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amgen, Inc.
- Inspection Date
- December 13, 2019
- Product Type
- Drugs
View Company Profile
ID · f7c02d35-9f41-4022-9b49-996bf75204ed
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1112791
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
1- 21 CFR 211.67(b)(6)Cleaning SOP/inspection
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Amgen, Inc.
29| 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 |
| March 16, 2018 | Not classified | Los Angeles District Office |
Other documents for Amgen, Inc.
- FDA Inspection 1278976 - 2025-08-07
- FDA Inspection 1256132 - 2025-03-13
- FDA Inspection 1240449 - 2024-02-06
- FDA Inspection 1220409 - 2023-09-14
- FDA Inspection 1046609 - 2018-03-16
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