FDA Inspection 830565 — Mercy Hospital Medical Center IRB
The FDA completed an inspection of Mercy Hospital Medical Center IRB on June 13, 2013 in Chicago, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 13, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 2966 | 21 CFR 812.66 | No IRB notification of significant risk determination |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7297 | 21 CFR 56.109(b) | Information given to subjects |
| 7337 | 21 CFR 56.115(b) | Retention of records |
| 7340 | 21 CFR 56.108(a)(3) | Prompt reporting of changes |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |
| 7370 | 21 CFR 56.111(c) | Children as subjects |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |
| 7373 | 21 CFR 56.109(c)(1) | Exception for informed consent; minimal risk study |