FDA Inspection 1177862 — Valley Health/Winchester Medical Center IRB
The FDA completed an inspection of Valley Health/Winchester Medical Center IRB on Aug 9, 2022 in Winchester, VA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 9, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Winchester, VA (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |