FDA inspection
St. John Hospital and Medical Center IRB: FDA inspection ending Jan 13, 2005
FDA inspection 371224 · Official Action Indicated (OAI) · Grosse Pointe Woods, MI
Key facts
| Inspection ID | 371224 |
|---|---|
| Firm | St. John Hospital and Medical Center IRB |
| FEI number | 1833142 |
| Address | 19251 Mack Ave Ste 340 |
| City | Grosse Pointe Woods |
| State | MI |
| ZIP | 48236-2891 |
| Fiscal year | 2005 |
| Inspection end date | Jan 13, 2005 |
| Classification | Official Action Indicated (OAI) |
| Project area | Product Evaluation: Med Devices |
| 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