Home / Companies / Columbia University Medical Center IRB

Columbia University Medical Center IRB FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Aug 31, 2022
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Columbia University Medical Center IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Columbia University Medical Center IRB" is on file.

What these totals cover: FDA records filed under the name "Columbia University Medical Center IRB".

Latest inspection: Aug 31, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	4	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Columbia University Medical Center IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Columbia University Medical Center IRB: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	1	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Columbia University Medical Center IRB as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Columbia University Medical Center IRB yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Recent FDA inspections

4 inspections from May 10, 2010 to Aug 31, 2022.

Date	Site	Product	Classification	FEI
Aug 31, 2022	New York, NY	Biologics	Voluntary Action Indicated (VAI)	2435189
May 31, 2017	New York, NY	Drugs	Voluntary Action Indicated (VAI)	2435189
Oct 14, 2011	New York, NY	Drugs	Voluntary Action Indicated (VAI)	2435189
May 10, 2010	New York, NY	Drugs	Voluntary Action Indicated (VAI)	2435189

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 2435189	New York, NY	4	Aug 31, 2022

Columbia University Medical Center IRB and the FDA: common questions

Has Columbia University Medical Center IRB received an FDA warning letter?

No FDA warning letter addressed to the name "Columbia University Medical Center IRB" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Columbia University Medical Center IRB received an FDA Form 483?

FDA has not published a Form 483 for "Columbia University Medical Center IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Columbia University Medical Center IRB?

The most recent FDA inspection on file ended Aug 31, 2022 at New York, NY and was classified VAI. FDA has 4 inspections of Columbia University Medical Center IRB on file.

Need more than this page shows? Ask about Columbia University Medical Center IRB in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.