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Froedtert Hospital Reproductive Medicine Center FDA Record

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

Latest inspection NAI · Aug 22, 2025
No warning letters matched by name

Inspections 7

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Froedtert Hospital Reproductive Medicine Center has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Froedtert Hospital Reproductive Medicine Center" is on file.

What these totals cover: FDA records filed under the name "Froedtert Hospital Reproductive Medicine Center".

Latest inspection: Aug 22, 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	7	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

Froedtert Hospital Reproductive Medicine Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Froedtert Hospital Reproductive Medicine 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	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	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

7 inspections from Feb 4, 2010 to Aug 22, 2025.

Date	Site	Product	Classification	FEI
Aug 22, 2025	Menomonee Falls, WI	Biologics	No Action Indicated (NAI)	3003241162
Dec 9, 2019	Menomonee Falls, WI	Biologics	No Action Indicated (NAI)	3003241162
Dec 7, 2017	Menomonee Falls, WI	Biologics	No Action Indicated (NAI)	3003241162
Dec 8, 2015	Menomonee Falls, WI	Biologics	Voluntary Action Indicated (VAI)	3003241162
Nov 8, 2013	Menomonee Falls, WI	Biologics	No Action Indicated (NAI)	3003241162
Jan 11, 2012	Menomonee Falls, WI	Biologics	Voluntary Action Indicated (VAI)	3003241162
Feb 4, 2010	Menomonee Falls, WI	Biologics	Voluntary Action Indicated (VAI)	3003241162

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 3003241162	Menomonee Falls, WI	7	Aug 22, 2025

Froedtert Hospital Reproductive Medicine Center and the FDA: common questions

Has Froedtert Hospital Reproductive Medicine Center received an FDA warning letter?

No FDA warning letter addressed to the name "Froedtert Hospital Reproductive Medicine 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 Froedtert Hospital Reproductive Medicine Center received an FDA Form 483?

FDA has not published a Form 483 for "Froedtert Hospital Reproductive Medicine Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Froedtert Hospital Reproductive Medicine Center?

The most recent FDA inspection on file ended Aug 22, 2025 at Menomonee Falls, WI and was classified NAI. FDA has 7 inspections of Froedtert Hospital Reproductive Medicine Center on file.

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