FDA inspection
Wayne State University Institutional Review Board: FDA inspection ending Feb 2, 2010
FDA inspection 645453 · Official Action Indicated (OAI) · Detroit, MI
Key facts
| Inspection ID | 645453 |
|---|---|
| Firm | Wayne State University Institutional Review Board |
| FEI number | 1824616 |
| Address | 87 E Canfield St Apt 2 |
| City | Detroit |
| State | MI |
| ZIP | 48202 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Feb 2, 2010 |
| Classification | Official Action Indicated (OAI) |
| Project area | Bioresearch Monitoring |
| Product type | Devices |
| Warning letter | 96105 |
At a glance
- 1–9 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