FDA Inspection 640526 — Trident Health System Irb
The FDA completed an inspection of Trident Health System Irb on Jan 25, 2010 in Charleston, SC. 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). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 25, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Charleston, SC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |