FDA Inspection 1117830 — Indiana University IRB
The FDA completed an inspection of Indiana University IRB on Feb 14, 2020 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 14, 2020
- Fiscal Year
- 2020
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7321 | 21 CFR 56.110(c) | Method to keep members advised |