FDA Inspection 1178562 — Columbia University Medical Center IRB
The FDA completed an inspection of Columbia University Medical Center IRB on August 31, 2022 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 31, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- New York, NY (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |