FDA inspection
Gener8: FDA inspection ending May 5, 2023
FDA inspection 1206007 · Voluntary Action Indicated (VAI) · San Jose, CA
Key facts
| Inspection ID | 1206007 |
|---|---|
| Firm | Gener8 |
| FEI number | 3012157621 |
| Address | 2560 Junction Ave |
| City | San Jose |
| State | CA |
| ZIP | 95134-1902 |
| Fiscal year | 2023 |
| Inspection end date | May 5, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Medical Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No 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