FDA Inspection 771895 — Northern Indiana Cancer Research Consortium IRB
The FDA completed an inspection of Northern Indiana Cancer Research Consortium IRB on February 21, 2012 in South Bend, IN. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- February 21, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- South Bend, IN (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 |