FDA Inspection 729057 — Trinity Medical Center-IRB
The FDA completed an inspection of Trinity Medical Center-IRB on Jun 24, 2011 in Rock Island, IL. 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). 11 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 24, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Rock Island, IL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 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 |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |