FDA Inspection 1012494 — Columbia University Medical Center IRB

Columbia University Medical Center IRB — FEI 2435189

The FDA completed an inspection of Columbia University Medical Center IRB on May 31, 2017 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: Drugs.

Inspection details

Classification
Voluntary Action Indicated (VAI)
End Date
May 31, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
New York, NY (United States)

Additional details

IRB

Citations

IDCFRDescription
727821 CFR 56.107(e)Conflict of interest
731821 CFR 56.115(a)(2)Minutes of IRB meetings

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