FDA Inspection 1281798 — Rush University System for Health IRB
The FDA completed an inspection of Rush University System for Health IRB on September 12, 2025 in Chicago, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Chicago, IL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7391 | 21 CFR 50.25(a)(5) | Confidentiality, FDA inspection of records |