FDA inspection
Seton Family of Hospitals Institutional Review Board (SFOH IRB): FDA inspection ending Mar 22, 2019
FDA inspection 1083450 · Voluntary Action Indicated (VAI) · Austin, TX
Key facts
| Inspection ID | 1083450 |
|---|---|
| Firm | Seton Family of Hospitals Institutional Review Board (SFOH IRB) |
| FEI number | 3001582178 |
| Address | 1345 Philomena St |
| City | Austin |
| State | TX |
| ZIP | 78723 |
| Country | United States |
| Fiscal year | 2019 |
| Inspection end date | Mar 22, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Biologics |
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