FDA inspection
Genetech Inc: FDA inspection ending Jun 22, 2018
FDA inspection 1057183 · Official Action Indicated (OAI) · San Diego, CA
Key facts
| Inspection ID | 1057183 |
|---|---|
| Firm | Genetech Inc |
| FEI number | 3013306140 |
| Address | 3030 Bunker Hill St Ste 308 |
| City | San Diego |
| State | CA |
| ZIP | 92109 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Jun 22, 2018 |
| Classification | Official Action Indicated (OAI) |
| Project area | Blood and Blood Products |
| Product type | Biologics |
| Warning letter | UCM628019 |
At a glance
- None 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