FDA Inspection 806943 — Cleveland Clinic Florida IRB
The FDA completed an inspection of Cleveland Clinic Florida IRB on Oct 22, 2012 in Weston, FL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 22, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Weston, FL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7305 | 21 CFR 56.110(b)(2) | Minor changes |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |