FDA Inspection 955872 — AtlantiCare Regional Medical Center IRB
The FDA completed an inspection of AtlantiCare Regional Medical Center IRB on February 4, 2016 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 4, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Atlantic City, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |