FDA inspection
Lutheran Hospital IRB: FDA inspection ending Jun 21, 2007
FDA inspection 477658 · Voluntary Action Indicated (VAI) · Fort Wayne, IN
Key facts
| Inspection ID | 477658 |
|---|---|
| Firm | Lutheran Hospital IRB |
| FEI number | 1827503 |
| Address | 7950 W Jefferson Blvd |
| City | Fort Wayne |
| State | IN |
| ZIP | 46804-4140 |
| Fiscal year | 2007 |
| Inspection end date | Jun 21, 2007 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med Devices |
| Product type | Devices |
At a glance
- None 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