817951
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 15, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Carbondale, IL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7353 | 21 CFR 50.52 | Factors required for approval |
| 7370 | 21 CFR 56.111(c) | Children as subjects |