FDA Inspection 765182 — Berkeley Biologics LLC
The FDA completed an inspection of Berkeley Biologics LLC on Feb 17, 2012 in Richmond, 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 17, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Richmond, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12309 | 21 CFR 1271.160(a) | Program is appropriate for the HCT/Ps |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12411 | 21 CFR 1271.260(a) | Contamination, mix ups, improper release |