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Covenant Medical Center Inc. IRB FDA Record

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

Latest inspection NAI · Jul 12, 2018
Last warning letter 2011

Inspections 3

1 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Sep 7, 2011

510(k) clearances 0 None on file

Covenant Medical Center Inc. IRB has 0 FDA recalls, 3 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Covenant Medical Center Inc. IRB, the most recent on Sep 7, 2011.

What these totals cover: FDA records filed under the name "Covenant Medical Center Inc. IRB".

Latest inspection: Jul 12, 2018 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	3	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

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Covenant Medical Center Inc. IRB FDA Warning Letters

1 warning letter on Sep 7, 2011.

Issued	Subject	Issuing office	Close-out letter
Sep 7, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Recent FDA inspections

3 inspections from Apr 20, 2011 to Jul 12, 2018.

Date	Site	Product	Classification	FEI
Jul 12, 2018	Saginaw, MI	Devices	No Action Indicated (NAI)	1000160433
May 2, 2012	Saginaw, MI	Drugs	Voluntary Action Indicated (VAI)	1000160433
Apr 20, 2011	Saginaw, MI	Drugs	Official Action Indicated (OAI)	1000160433

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Covenant Medical Center Inc. IRB: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 7, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1000160433	Saginaw, MI	3	Jul 12, 2018

Covenant Medical Center Inc. IRB and the FDA: common questions

Has Covenant Medical Center Inc. IRB received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Covenant Medical Center Inc. IRB. The most recent is dated Sep 7, 2011.

Has Covenant Medical Center Inc. IRB received an FDA Form 483?

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

When did the FDA last inspect Covenant Medical Center Inc. IRB?

The most recent FDA inspection on file ended Jul 12, 2018 at Saginaw, MI and was classified NAI. FDA has 3 inspections of Covenant Medical Center Inc. IRB on file, 1 of them classified OAI (official action indicated).

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