FDA Inspection 965949 — William Beaumont Hospital IRB
The FDA completed an inspection of William Beaumont Hospital IRB on Feb 19, 2016 in Royal Oak, 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 19, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Royal Oak, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7652 | 21 CFR 56.113 | Reporting |