FDA Inspection 628805 — Children's Hospital Medical Center Of Akron IRB
The FDA completed an inspection of Children's Hospital Medical Center Of Akron IRB on Nov 18, 2009 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). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 18, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- 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 |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |