FDA inspection
Berkeley Biologics LLC: FDA inspection ending Sep 25, 2023
FDA inspection 1218588 · Official Action Indicated (OAI) · Richmond, CA
Key facts
| Inspection ID | 1218588 |
|---|---|
| Firm | Berkeley Biologics LLC |
| FEI number | 1000100754 |
| Address | 880 Harbour Way S Ste 100 |
| City | Richmond |
| State | CA |
| ZIP | 94804 |
| Country | United States |
| Fiscal year | 2023 |
| Inspection end date | Sep 25, 2023 |
| Classification | Official Action Indicated (OAI) |
| Project area | Human Cellular, Tissue, and Gene Therapies |
| Product type | Biologics |
| Warning letter | 676984 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data