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Trinity Health Michigan Regional IRB #4 FDA Record

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

Latest inspection NAI · Jul 16, 2025
Last warning letter 2015

Inspections 4

2 OAI

Recalls 0 0 Class I

Warning letters 2 Latest Sep 15, 2015

510(k) clearances 0 None on file

Trinity Health Michigan Regional IRB #4 has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 2 compliance actions on record. FDA has issued 2 warning letters to Trinity Health Michigan Regional IRB #4, the most recent on Sep 15, 2015.

What these totals cover: FDA records filed under the name "Trinity Health Michigan Regional IRB #4".

Latest inspection: Jul 16, 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	2	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Trinity Health Michigan Regional IRB #4's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Trinity Health Michigan Regional IRB #4: 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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Trinity Health Michigan Regional IRB #4 FDA Warning Letters

2 warning letters from Aug 1, 2013 to Sep 15, 2015.

Issued	Subject	Issuing office	Close-out letter
Sep 15, 2015 · Record page
Aug 1, 2013 · 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 Apr 22, 2013 to Jul 16, 2025.

Date	Site	Product	Classification	FEI
Jul 16, 2025	Pontiac, MI	Devices	No Action Indicated (NAI)	1825380
Sep 14, 2018	Pontiac, MI	Devices	Voluntary Action Indicated (VAI)	1825380
Apr 21, 2015	Pontiac, MI	Devices	Official Action Indicated (OAI)	1825380
Apr 22, 2013	Pontiac, MI	Devices	Official Action Indicated (OAI)	1825380

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 2 compliance actions under Trinity Health Michigan Regional IRB #4: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 15, 2015.

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 1825380	Pontiac, MI	4	Jul 16, 2025

Trinity Health Michigan Regional IRB #4 and the FDA: common questions

Has Trinity Health Michigan Regional IRB #4 received an FDA warning letter?

Yes. FDA has issued 2 warning letters to Trinity Health Michigan Regional IRB #4. The most recent is dated Sep 15, 2015.

Has Trinity Health Michigan Regional IRB #4 received an FDA Form 483?

FDA has not published a Form 483 for "Trinity Health Michigan Regional IRB #4" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Trinity Health Michigan Regional IRB #4?

The most recent FDA inspection on file ended Jul 16, 2025 at Pontiac, MI and was classified NAI. FDA has 4 inspections of Trinity Health Michigan Regional IRB #4 on file, 2 of them classified OAI (official action indicated).

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