FDA Inspection 837193 — Amgen, Inc.
The FDA completed an inspection of Amgen, Inc. on June 17, 2013 in Thousand Oaks, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 17, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Thousand Oaks, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |