FDA Inspection 651182 — Hospital Of St. Raphael/IRC
The FDA completed an inspection of Hospital Of St. Raphael/IRC on Mar 4, 2010 in New Haven, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 4, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- New Haven, CT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |