FDA Inspection 1178562 — Columbia University Medical Center IRB
The FDA completed an inspection of Columbia University Medical Center IRB on Aug 31, 2022 in New York, NY. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 31, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- 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 |