FDA Inspection 766112 — U. Of Connecticut Hlth Ctr. IRB
The FDA completed an inspection of U. Of Connecticut Hlth Ctr. IRB on Feb 3, 2012 in Farmington, 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 3, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Farmington, CT (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7393 | 21 CFR 50.25(a)(8) | Participation; refusal and discontinuance |