FDA Inspection 1306566 — Catholic Health Initiatives Institute for Research and Innovation IRB
The FDA completed an inspection of Catholic Health Initiatives Institute for Research and Innovation IRB on March 3, 2026 in Englewood, CO. 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
- March 3, 2026
- Fiscal Year
- 2026
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Englewood, CO (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7325 | 21 CFR 56.111(a)(5) | Informed consent documented |