1060799
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Bozeman, MT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |
| 7326 | 21 CFR 56.111(a)(6) | Monitoring of data collected |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7653 | 21 CFR 56.111(a)(1) | Risks minimized by using procedures already being performed |