FDA Inspection 958208 — Mercy Health System IRB
The FDA completed an inspection of Mercy Health System IRB on February 1, 2016 in Janesville, WI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 1, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Janesville, WI (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7339 | 21 CFR 56.108(a)(4) | Changes in approved research |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |