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Rush University System For Health IRB FDA Record

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

Latest inspection VAI · Sep 12, 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

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

What these totals cover: FDA records filed under the name "Rush University System For Health IRB".

Latest inspection: Sep 12, 2025 · VAI

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 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Rush University System For Health IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Rush University System For Health 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 Apr 2, 2010 to Sep 12, 2025.

Date	Site	Product	Classification	FEI
Sep 12, 2025	Chicago, IL	Devices	Voluntary Action Indicated (VAI)	3001770544
May 18, 2018	Chicago, IL	Devices	No Action Indicated (NAI)	3001770544
Nov 13, 2013	Chicago, IL	Drugs	Voluntary Action Indicated (VAI)	3001770544
Apr 2, 2010	Chicago, IL	Devices	Voluntary Action Indicated (VAI)	3001770544

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 3001770544	Chicago, IL	4	Sep 12, 2025

Rush University System For Health IRB and the FDA: common questions

Has Rush University System For Health IRB received an FDA warning letter?

No FDA warning letter addressed to the name "Rush University System For Health 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 Rush University System For Health IRB received an FDA Form 483?

FDA has not published a Form 483 for "Rush University System For Health IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Rush University System For Health IRB?

The most recent FDA inspection on file ended Sep 12, 2025 at Chicago, IL and was classified VAI. FDA has 4 inspections of Rush University System For Health IRB on file.

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