FDA inspection
Lutheran Hospital IRB: FDA inspection ending May 10, 2013
FDA inspection 834002 · Voluntary Action Indicated (VAI) · Fort Wayne, IN
Key facts
| Inspection ID | 834002 |
|---|---|
| Firm | Lutheran Hospital IRB |
| FEI number | 1827503 |
| Address | 7950 W Jefferson Blvd |
| City | Fort Wayne |
| State | IN |
| ZIP | 46804 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | May 10, 2013 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| 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