FDA Inspection 708051 — CAMC-WVU Charleston Division IRB
The FDA completed an inspection of CAMC-WVU Charleston Division IRB on February 3, 2011 in Charleston, WV. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 3, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Charleston, WV (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |