FDA Inspection 779831 — Memorial Hospital Of South Bend, IRB
The FDA completed an inspection of Memorial Hospital Of South Bend, IRB on April 23, 2012 in South Bend, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 23, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South Bend, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7276 | 21 CFR 56.107(c) | One scientific and one non-scientific member |
| 7278 | 21 CFR 56.107(e) | Conflict of interest |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7370 | 21 CFR 56.111(c) | Children as subjects |