FDA Inspection 755897 — Medical Central Health System IRB #1
The FDA completed an inspection of Medical Central Health System IRB #1 on December 7, 2011 in Mansfield, OH. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2011
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Mansfield, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7335 | 21 CFR 56.115(a)(6) | Written procedures per 56.108(a) and (b) |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |