FDA Inspection 1060799 — Montana State University- Bozeman IRB
The FDA completed an inspection of Montana State University- Bozeman IRB on Aug 2, 2018 in Bozeman, MT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 2, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- 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 |