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Aurora St. Luke's Medical Center FDA Record

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

Latest inspection VAI · Jun 24, 2025
No warning letters matched by name

Inspections 9

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Aurora St. Luke's Medical Center has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Aurora St. Luke's Medical Center" is on file. FDA has published 1 Form 483 for Aurora St. Luke's Medical Center.

What these totals cover: FDA records filed under the name "Aurora St. Luke's Medical Center" and its spelling variant "Aurora St. Luke Medical Center".

Latest inspection: Jun 24, 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	9	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

Aurora St. Luke's Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Aurora St. Luke's Medical Center: 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	1	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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Aurora St. Luke's Medical Center Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Jun 24, 2025 · Document on fda.gov	483	1000389954

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

9 inspections from Oct 9, 2008 to Jun 24, 2025.

Date	Site	Product	Classification	FEI
Jun 24, 2025	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Jun 23, 2022	Milwaukee, WI	Biologics	No Action Indicated (NAI)	1000389954
Apr 4, 2018	Milwaukee, WI	Biologics	No Action Indicated (NAI)	1000389954
Mar 23, 2016	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Sep 25, 2015	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Dec 9, 2013	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Mar 8, 2012	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Oct 8, 2009	Milwaukee, WI	Biologics	Voluntary Action Indicated (VAI)	1000389954
Oct 9, 2008	Milwaukee, WI	Biologics	No Action Indicated (NAI)	1000389954

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 1000389954	Milwaukee, WI	9	Jun 24, 2025

Aurora St. Luke's Medical Center and the FDA: common questions

Has Aurora St. Luke's Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "Aurora St. Luke's Medical Center" 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 Aurora St. Luke's Medical Center received an FDA Form 483?

FDA has published 1 Form 483 for Aurora St. Luke's Medical Center in its reading room, the most recent dated Jun 24, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Aurora St. Luke's Medical Center?

The most recent FDA inspection on file ended Jun 24, 2025 at Milwaukee, WI and was classified VAI. FDA has 9 inspections of Aurora St. Luke's Medical Center on file.

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