FDA Inspection 980791 — Community Health Network IRB
The FDA completed an inspection of Community Health Network IRB on April 14, 2016 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 14, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 1 | 21 CFR 11 | Electronic records |
| 7298 | 21 CFR 56.109(a) | Authority of the IRB |
| 7316 | 21 CFR 56.115(a)(4) | Copies of IRB/CI correspondence |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |
| 7334 | 21 CFR 56.115(a)(5) | List of members |