FDA Inspection 779241 — Women & Infants Hospital IRB
The FDA completed an inspection of Women & Infants Hospital IRB on March 23, 2012 in Pawtucket, RI. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Pawtucket, RI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7370 | 21 CFR 56.111(c) | Children as subjects |