FDA Inspection 776083 — Ascension St. John Hospital IRB
The FDA completed an inspection of Ascension St. John Hospital IRB on Mar 21, 2012 in Grosse Pointe Woods, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 21, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Grosse Pointe Woods, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2916 | 21 CFR 812.7(d) | Investigational device represented as safe and /or effective |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |