FDA Inspection 696746 — St Barnabas Medical Center IRB
The FDA completed an inspection of St Barnabas Medical Center IRB on November 2, 2010 in Livingston, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Livingston, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |