FDA Inspection 552269 — Valley Health/Winchester Medical Center IRB
The FDA completed an inspection of Valley Health/Winchester Medical Center IRB on Nov 12, 2008 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 12, 2008
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Winchester, VA (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |