FDA Inspection 1178562 — Columbia University Medical Center IRB

Columbia University Medical Center IRB — FEI 2435189

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

IDCFRDescription
729021 CFR 56.108(c)Members present for review
731821 CFR 56.115(a)(2)Minutes of IRB meetings

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.