FDA Inspection 1256132 — Amgen, Inc.
The FDA completed an inspection of Amgen, Inc. on Mar 13, 2025 in Thousand Oaks, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 13, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 22921 | FDCA 582(b)(4) | Systems in place to comply with verification requirements |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |
| 4576 | 21 CFR 211.192 | No written record of investigation |