FDA Inspection 1056932 — St. Rita's Medical Center IRB
The FDA completed an inspection of St. Rita's Medical Center IRB on Jun 26, 2018 in Lima, OH. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 26, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lima, OH (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7317 | 21 CFR 56.115(a)(1) | Copies of all research proposals and related documents |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |