FDA Inspection 1256931 — Berkeley Advanced Biomaterials, LLC
The FDA completed an inspection of Berkeley Advanced Biomaterials, LLC on Nov 22, 2024 in Berkeley, 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
- Nov 22, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Berkeley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12363 | 21 CFR 1271.195(c) | Monitoring--cross contamination, exposure to CD |
| 12387 | 21 CFR 1271.220(a) | Causing contamination, increasing risks |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |