FDA inspection
Ascension St. John Hospital IRB: FDA inspection ending Dec 23, 2016
FDA inspection 997372 · Voluntary Action Indicated (VAI) · Grosse Pointe Woods, MI
Key facts
| Inspection ID | 997372 |
|---|---|
| Firm | Ascension St. John Hospital IRB |
| FEI number | 1833142 |
| Address | 19251 Mack Ave Ste 340 |
| City | Grosse Pointe Woods |
| State | MI |
| ZIP | 48236 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Dec 23, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Bioresearch Monitoring |
| Product type | Drugs |
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