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University Of Michigan Center For Reproductive Medicine FDA Record

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

Latest inspection NAI · Jun 2, 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

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

What these totals cover: FDA records filed under the name "University Of Michigan Center For Reproductive Medicine".

Latest inspection: Jun 2, 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

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

University Of Michigan Center For Reproductive Medicine: 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	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

7 inspections from Mar 2, 2009 to Jun 2, 2025.

Date	Site	Product	Classification	FEI
Jun 2, 2025	Ann Arbor, MI	Biologics	No Action Indicated (NAI)	3003974918
Feb 14, 2019	Ann Arbor, MI	Biologics	No Action Indicated (NAI)	3003974918
Mar 20, 2018	Ann Arbor, MI	Biologics	Voluntary Action Indicated (VAI)	3003974918
Jan 7, 2016	Ann Arbor, MI	Biologics	No Action Indicated (NAI)	3003974918
Jul 25, 2013	Ann Arbor, MI	Biologics	Voluntary Action Indicated (VAI)	3003974918
Jun 22, 2011	Ann Arbor, MI	Biologics	No Action Indicated (NAI)	3003974918
Mar 2, 2009	Ann Arbor, MI	Biologics	Voluntary Action Indicated (VAI)	3003974918

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 3003974918	Ann Arbor, MI	7	Jun 2, 2025

University Of Michigan Center For Reproductive Medicine and the FDA: common questions

Has University Of Michigan Center For Reproductive Medicine received an FDA warning letter?

No FDA warning letter addressed to the name "University Of Michigan Center For Reproductive Medicine" 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 University Of Michigan Center For Reproductive Medicine received an FDA Form 483?

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

When did the FDA last inspect University Of Michigan Center For Reproductive Medicine?

The most recent FDA inspection on file ended Jun 2, 2025 at Ann Arbor, MI and was classified NAI. FDA has 7 inspections of University Of Michigan Center For Reproductive Medicine on file.

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