FDA Inspection 1196982 — AtlantiCare Regional Medical Center IRB
The FDA completed an inspection of AtlantiCare Regional Medical Center IRB on February 10, 2023 in Atlantic City, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 10, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Atlantic City, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7304 | 21 CFR 56.110(b)(1) | No more than minimal risk |
| 7319 | 21 CFR 56.115(a)(3) | Records of continuing review |