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KMI IMI Group FDA Record

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

KMI IMI Group has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to KMI IMI Group, the most recent on Mar 19, 2013.

What these totals cover: FDA records filed under the name "KMI IMI Group".

Latest inspection: Apr 15, 2025 · 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	6	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

KMI IMI Group's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

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	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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KMI IMI Group FDA Warning Letters

1 warning letter on Mar 19, 2013.

Issued	Subject	Issuing office	Close-out letter
Mar 19, 2013

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

6 inspections from Aug 5, 2010 to Apr 15, 2025.

Date	Site	Product	Classification	FEI
Apr 15, 2025	Irvine, CA	Devices	No Action Indicated (NAI)	3004112621
Mar 8, 2018	Irvine, CA	Devices	Voluntary Action Indicated (VAI)	3004112621
Dec 17, 2013	Irvine, CA	Devices	No Action Indicated (NAI)	3004112621
Oct 9, 2012	Irvine, CA	Devices	Official Action Indicated (OAI)	3004112621
Aug 17, 2011	Irvine, CA	Devices	No Action Indicated (NAI)	3004112621
Aug 5, 2010	Irvine, CA	Devices	Voluntary Action Indicated (VAI)	3004112621

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 KMI IMI Group: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 19, 2013.

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 3004112621	Irvine, CA	6	Apr 15, 2025

KMI IMI Group and the FDA: common questions

Has KMI IMI Group received an FDA warning letter?

Yes. FDA has issued 1 warning letter to KMI IMI Group. The most recent is dated Mar 19, 2013.

Has KMI IMI Group received an FDA Form 483?

FDA has not published a Form 483 for "KMI IMI Group" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect KMI IMI Group?

The most recent FDA inspection on file ended Apr 15, 2025 at Irvine, CA and was classified NAI. FDA has 6 inspections of KMI IMI Group on file, 1 of them classified OAI (official action indicated).

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