FDA inspection
Santa Clara Valley Medical Center IRB: FDA inspection ending Sep 19, 2014
FDA inspection 898684 · Official Action Indicated (OAI) · San Jose, CA
Key facts
| Inspection ID | 898684 |
|---|---|
| Firm | Santa Clara Valley Medical Center IRB |
| FEI number | 1000100855 |
| Address | 751 S Bascom Ave |
| City | San Jose |
| State | CA |
| ZIP | 95128 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Sep 19, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bioresearch Monitoring |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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