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University Hospitals Cleveland Medical Center FDA Record

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

Latest inspection NAI · Mar 26, 2025
No warning letters matched by name

Inspections 10

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

University Hospitals Cleveland Medical Center has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Hospitals Cleveland Medical Center" is on file.

What these totals cover: FDA records filed under the name "University Hospitals Cleveland Medical Center".

Latest inspection: Mar 26, 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	10	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 Hospitals Cleveland Medical Center's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

University Hospitals Cleveland 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	1	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

10 inspections from Nov 6, 2008 to Mar 26, 2025.

Date	Site	Product	Classification	FEI
Mar 26, 2025	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
May 30, 2023	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Oct 23, 2019	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Nov 30, 2017	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Oct 8, 2015	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Dec 11, 2013	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Mar 23, 2012	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Jul 27, 2010	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323
Aug 24, 2009	Cleveland, OH	Biologics	Voluntary Action Indicated (VAI)	1570323
Nov 6, 2008	Cleveland, OH	Biologics	No Action Indicated (NAI)	1570323

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 1570323	Cleveland, OH	10	Mar 26, 2025

University Hospitals Cleveland Medical Center and the FDA: common questions

Has University Hospitals Cleveland Medical Center received an FDA warning letter?

No FDA warning letter addressed to the name "University Hospitals Cleveland 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 University Hospitals Cleveland Medical Center received an FDA Form 483?

FDA has not published a Form 483 for "University Hospitals Cleveland Medical Center" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect University Hospitals Cleveland Medical Center?

The most recent FDA inspection on file ended Mar 26, 2025 at Cleveland, OH and was classified NAI. FDA has 10 inspections of University Hospitals Cleveland Medical Center on file.

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