FDA Inspection 854419 — Akron General Medical Center Institutional Research Review Board
The FDA completed an inspection of Akron General Medical Center Institutional Research Review Board on Nov 7, 2013 in Akron, OH. 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
- Nov 7, 2013
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Akron, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7370 | 21 CFR 56.111(c) | Children as subjects |