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Columbia University Medical Center IRB FDA Inspection Record

FEI 2435189 · Inspections, Form 483s, warning letters and import refusals

Columbia University Medical Center IRB is an FDA-inspected facility (FEI 2435189) located in New York, NY, US. RegDataLab tracks 4 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Aug 31, 2022: Voluntary Action Indicated (VAI)
Inspections on record
4 (4 VAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Aug 31, 2022Voluntary Action Indicated (VAI)Members present for review (21 CFR 56.108(c))
Minutes of IRB meetings (21 CFR 56.115(a)(2))
May 31, 2017Voluntary Action Indicated (VAI)Conflict of interest (21 CFR 56.107(e))
Minutes of IRB meetings (21 CFR 56.115(a)(2))
Oct 14, 2011Voluntary Action Indicated (VAI)No citations listed
May 10, 2010Voluntary Action Indicated (VAI)Members present for review (21 CFR 56.108(c))
Minutes of IRB meetings (21 CFR 56.115(a)(2))
List of members (21 CFR 56.115(a)(5))

FDA record score

5 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

4 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIAug 31, 20226 x 0.63.6
Inspection classified VAIMay 31, 20176 x 0.251.5
Inspection classified VAIOct 14, 201110 years or older, so it adds no points0
Inspection classified VAIMay 10, 201010 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
Columbia University Medical Center IRB
Location
New York, NY (US)
Source
inspections

FDA data resources

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