FDA Inspection 1065554 — HealthEast Institutional Review Board
The FDA completed an inspection of HealthEast Institutional Review Board on Sep 13, 2018 in Saint Paul, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |