FDA Inspection 551112 — Henry Ford Health System Institutional Review Board
The FDA completed an inspection of Henry Ford Health System Institutional Review Board on Nov 10, 2008 in Detroit, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 10, 2008
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Detroit, MI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7634 | 21 CFR 312.7(a) | Promotion of Investigational Drug |