FDA Inspection 814089 — HealthEast Institutional Review Board
The FDA completed an inspection of HealthEast Institutional Review Board on Jan 3, 2013 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
- Jan 3, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Saint Paul, MN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7387 | 21 CFR 50.25(a)(1) | Statement of research, purpose, duration of participation |
| 7389 | 21 CFR 50.25(a)(3) | Benefits to the subject |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |