FDA Inspection 629842 — Cooper Health System IRB
The FDA completed an inspection of Cooper Health System IRB on November 6, 2009 in Camden, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 6, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Camden, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |