FDA Inspection
Amgen, Inc.Amgen, Inc. – FDA Inspection, Jun 3, 2010
Record Details
This FDA Inspection record concerns Amgen, Inc., with an inspection on June 3, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Amgen, Inc.
- Inspection Date
- June 3, 2010
- Product Type
- Drugs
View Company Profile
ID · 99e9856b-8b9c-431b-aa4f-058b62cb02a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 674567
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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 |
| December 13, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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 1112791 - 2019-12-13
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