FDA Inspection 816048 — Valley Health/Winchester Medical Center IRB
The FDA completed an inspection of Valley Health/Winchester Medical Center IRB on Feb 1, 2013 in Winchester, VA. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Feb 1, 2013
- Fiscal Year
- 2013
- 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 |