551112
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 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 |