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University Hospitals Cleveland Medical Center IRB FDA Record

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

Latest inspection NAI · Oct 22, 2021
No warning letters matched by name

Inspections 3

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 IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "University Hospitals Cleveland Medical Center IRB" is on file.

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

Latest inspection: Oct 22, 2021 · 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	3	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 IRB'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 IRB: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	1	0	0	0	0
2020	0	0	0	0	0
2019	0	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

3 inspections from Dec 6, 2011 to Oct 22, 2021.

Date	Site	Product	Classification	FEI
Oct 22, 2021	Cleveland, OH	Drugs	No Action Indicated (NAI)	1525792
Sep 19, 2017	Cleveland, OH	Devices	Voluntary Action Indicated (VAI)	1525792
Dec 6, 2011	Cleveland, OH	Drugs	Voluntary Action Indicated (VAI)	1525792

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 1525792	Cleveland, OH	3	Oct 22, 2021

University Hospitals Cleveland Medical Center IRB and the FDA: common questions

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

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

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

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

The most recent FDA inspection on file ended Oct 22, 2021 at Cleveland, OH and was classified NAI. FDA has 3 inspections of University Hospitals Cleveland Medical Center IRB on file.

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