FDA Inspection 1050583 — Sunrise Health Institutional Review Board
The FDA completed an inspection of Sunrise Health Institutional Review Board on May 3, 2018 in Las Vegas, NV. 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). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 3, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Las Vegas, NV (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7313 | 21 CFR 56.112 | Approval by institution in absence of IRB approval |