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University Of Chicago Biological Sciences Division IRB FDA Record

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

Latest inspection NAI · Jul 18, 2025
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

University Of Chicago Biological Sciences Division IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Of Chicago Biological Sciences Division IRB" is on file.

What these totals cover: FDA records filed under the name "University Of Chicago Biological Sciences Division IRB".

Latest inspection: Jul 18, 2025 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 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

University Of Chicago Biological Sciences Division IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

University Of Chicago Biological Sciences Division IRB: FDA inspections per year

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

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Recent FDA inspections

4 inspections from Jul 8, 2009 to Jul 18, 2025.

Date	Site	Product	Classification	FEI
Jul 18, 2025	Chicago, IL	Biologics	No Action Indicated (NAI)	1470158
May 2, 2018	Chicago, IL	Devices	No Action Indicated (NAI)	1470158
Jan 10, 2014	Chicago, IL	Devices	No Action Indicated (NAI)	1470158
Jul 8, 2009	Chicago, IL	Devices	Voluntary Action Indicated (VAI)	1470158

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 1470158	Chicago, IL	4	Jul 18, 2025

University Of Chicago Biological Sciences Division IRB and the FDA: common questions

Has University Of Chicago Biological Sciences Division IRB received an FDA warning letter?

No FDA warning letter addressed to the name "University Of Chicago Biological Sciences Division 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 University Of Chicago Biological Sciences Division IRB received an FDA Form 483?

FDA has not published a Form 483 for "University Of Chicago Biological Sciences Division IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect University Of Chicago Biological Sciences Division IRB?

The most recent FDA inspection on file ended Jul 18, 2025 at Chicago, IL and was classified NAI. FDA has 4 inspections of University Of Chicago Biological Sciences Division IRB on file.

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