FDA Inspection 865408 — St. Peter's University Hospital - CPHSR
The FDA completed an inspection of St. Peter's University Hospital - CPHSR on January 13, 2014 in New Brunswick, NJ. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 13, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- New Brunswick, NJ (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7370 | 21 CFR 56.111(c) | Children as subjects |