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Corewell Health William Beaumont University Hospital FDA Record

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

Latest inspection NAI · Jul 11, 2025
No warning letters matched by name

Inspections 8

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Corewell Health William Beaumont University Hospital has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Corewell Health William Beaumont University Hospital" is on file.

What these totals cover: FDA records filed under the name "Corewell Health William Beaumont University Hospital".

Latest inspection: Jul 11, 2025 · NAI

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	8	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

Corewell Health William Beaumont University Hospital's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Corewell Health William Beaumont University Hospital: 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	1	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

8 inspections from Jul 15, 2009 to Jul 11, 2025.

Date	Site	Product	Classification	FEI
Jul 11, 2025	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Apr 14, 2023	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Jul 16, 2018	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Sep 8, 2016	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Dec 12, 2014	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Feb 25, 2013	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566
Jan 25, 2011	Royal Oak, MI	Biologics	Voluntary Action Indicated (VAI)	1872566
Jul 15, 2009	Royal Oak, MI	Biologics	No Action Indicated (NAI)	1872566

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 1872566	Royal Oak, MI	8	Jul 11, 2025

Corewell Health William Beaumont University Hospital and the FDA: common questions

Has Corewell Health William Beaumont University Hospital received an FDA warning letter?

No FDA warning letter addressed to the name "Corewell Health William Beaumont University Hospital" 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 Corewell Health William Beaumont University Hospital received an FDA Form 483?

FDA has not published a Form 483 for "Corewell Health William Beaumont University Hospital" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Corewell Health William Beaumont University Hospital?

The most recent FDA inspection on file ended Jul 11, 2025 at Royal Oak, MI and was classified NAI. FDA has 8 inspections of Corewell Health William Beaumont University Hospital on file.

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