FDA Inspection 1218588 — Berkeley Biologics LLC
The FDA completed an inspection of Berkeley Biologics LLC on Sep 25, 2023 in Richmond, CA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 25, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Richmond, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12322 | 21 CFR 1271.160(b)(4) | Training of personnel |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |