FDA Inspection 655377 — Connecticut Children's Medical Center Institutional Review Board
The FDA completed an inspection of Connecticut Children's Medical Center Institutional Review Board on Mar 31, 2010 in Hartford, 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
- Mar 31, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Hartford, CT (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |
| 7392 | 21 CFR 50.25(a)(7) | Whom to contact |