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UP Health System Marquette IRB FDA Record

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

Latest inspection NAI · Aug 27, 2025
Last warning letter 2011

Inspections 4

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Jan 18, 2011

510(k) clearances 0 None on file

UP Health System Marquette IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to UP Health System Marquette IRB, the most recent on Jan 18, 2011.

What these totals cover: FDA records filed under the name "UP Health System Marquette IRB".

Latest inspection: Aug 27, 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 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

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

UP Health System Marquette 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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UP Health System Marquette IRB FDA Warning Letters

1 warning letter on Jan 18, 2011.

Issued	Subject	Issuing office	Close-out letter
Jan 18, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

4 inspections from Oct 21, 2010 to Aug 27, 2025.

Date	Site	Product	Classification	FEI
Aug 27, 2025	Marquette, MI	Drugs	No Action Indicated (NAI)	1828413
Nov 8, 2018	Marquette, MI	Drugs	No Action Indicated (NAI)	1828413
Sep 20, 2012	Marquette, MI	Devices	Voluntary Action Indicated (VAI)	1828413
Oct 21, 2010	Marquette, MI	Devices	Official Action Indicated (OAI)	1828413

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under UP Health System Marquette IRB: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 18, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1828413	Marquette, MI	4	Aug 27, 2025

UP Health System Marquette IRB and the FDA: common questions

Has UP Health System Marquette IRB received an FDA warning letter?

Yes. FDA has issued 1 warning letter to UP Health System Marquette IRB. The most recent is dated Jan 18, 2011.

Has UP Health System Marquette IRB received an FDA Form 483?

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

When did the FDA last inspect UP Health System Marquette IRB?

The most recent FDA inspection on file ended Aug 27, 2025 at Marquette, MI and was classified NAI. FDA has 4 inspections of UP Health System Marquette IRB on file, 1 of them classified OAI (official action indicated).

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