FDA Inspection 566490 — Virtua Health IRB
The FDA completed an inspection of Virtua Health IRB on Feb 25, 2009 in Marlton, NJ. 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
- Feb 25, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Marlton, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |