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Mayo Clinic Rochester, Division Of Transfusion Medicine FDA Record

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

Latest inspection NAI · Sep 17, 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

Mayo Clinic Rochester, Division Of Transfusion Medicine has 0 FDA recalls, 8 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mayo Clinic Rochester, Division Of Transfusion Medicine" is on file.

What these totals cover: FDA records filed under the name "Mayo Clinic Rochester, Division Of Transfusion Medicine".

Latest inspection: Sep 17, 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

Mayo Clinic Rochester, Division Of Transfusion Medicine's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Mayo Clinic Rochester, Division Of Transfusion 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	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 Feb 1, 2010 to Sep 17, 2025.

Date	Site	Product	Classification	FEI
Sep 17, 2025	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Nov 15, 2023	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Nov 1, 2018	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Nov 2, 2016	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Jun 25, 2015	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Feb 8, 2013	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Feb 18, 2011	Rochester, MN	Biologics	No Action Indicated (NAI)	2172560
Feb 1, 2010	Rochester, MN	Biologics	Voluntary Action Indicated (VAI)	2172560

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 2172560	Rochester, MN	8	Sep 17, 2025

Mayo Clinic Rochester, Division Of Transfusion Medicine and the FDA: common questions

Has Mayo Clinic Rochester, Division Of Transfusion Medicine received an FDA warning letter?

No FDA warning letter addressed to the name "Mayo Clinic Rochester, Division Of Transfusion 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 Mayo Clinic Rochester, Division Of Transfusion Medicine received an FDA Form 483?

FDA has not published a Form 483 for "Mayo Clinic Rochester, Division Of Transfusion Medicine" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Mayo Clinic Rochester, Division Of Transfusion Medicine?

The most recent FDA inspection on file ended Sep 17, 2025 at Rochester, MN and was classified NAI. FDA has 8 inspections of Mayo Clinic Rochester, Division Of Transfusion Medicine on file.

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