FDA Inspection 662702 — William Backus Hospital Irb
The FDA completed an inspection of William Backus Hospital Irb on May 19, 2010 in Norwich, 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
- May 19, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Norwich, CT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |