791741
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Anniston, AL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |