FDA Inspection 829974 — Trinity Health Michigan Regional IRB #4
The FDA completed an inspection of Trinity Health Michigan Regional IRB #4 on Apr 22, 2013 in Pontiac, MI. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Apr 22, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Pontiac, MI (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 |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7343 | 21 CFR 56.108(b)(3) | Reporting of suspension/termination |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7652 | 21 CFR 56.113 | Reporting |
| 7653 | 21 CFR 56.111(a)(1) | Risks minimized by using procedures already being performed |