FDA Inspection 766112 — U. of Connecticut Hlth Ctr. IRB
The FDA completed an inspection of U. of Connecticut Hlth Ctr. IRB on February 3, 2012 in Farmington, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 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 |