1065554
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 13, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |