FDA Inspection 653944 — Medical Central Health System IRB #1
The FDA completed an inspection of Medical Central Health System IRB #1 on March 31, 2010 in Mansfield, OH. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 31, 2010
- Fiscal Year
- 2010
- 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 |
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |