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University Of Minnesota IRB FDA Record

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

Latest inspection NAI · May 28, 2025
No warning letters matched by name

Inspections 4

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

University Of Minnesota IRB has 0 FDA recalls, 4 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Of Minnesota IRB" is on file.

What these totals cover: FDA records filed under the name "University Of Minnesota IRB".

Latest inspection: May 28, 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	4	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 Minnesota IRB's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

University Of Minnesota IRB: 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	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

4 inspections from Oct 18, 2011 to May 28, 2025.

Date	Site	Product	Classification	FEI
May 28, 2025	Minneapolis, MN	Drugs	No Action Indicated (NAI)	2127205
Dec 12, 2019	Minneapolis, MN	Drugs	No Action Indicated (NAI)	2127205
Sep 25, 2015	Minneapolis, MN	Drugs	Voluntary Action Indicated (VAI)	2127205
Oct 18, 2011	Minneapolis, MN	Devices	Voluntary Action Indicated (VAI)	2127205

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 2127205	Minneapolis, MN	4	May 28, 2025

University Of Minnesota IRB and the FDA: common questions

Has University Of Minnesota IRB received an FDA warning letter?

No FDA warning letter addressed to the name "University Of Minnesota IRB" 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 Minnesota IRB received an FDA Form 483?

FDA has not published a Form 483 for "University Of Minnesota IRB" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect University Of Minnesota IRB?

The most recent FDA inspection on file ended May 28, 2025 at Minneapolis, MN and was classified NAI. FDA has 4 inspections of University Of Minnesota IRB on file.

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