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KMI IMI GROUP / DBA: INNOVATIVE MED, INC. FDA Inspection Record

FEI 3004112621 · Inspections, Form 483s, warning letters and import refusals

KMI IMI GROUP / DBA: INNOVATIVE MED, INC. is an FDA-registered facility (FEI 3004112621) located in IRVINE, CA, US. RegDataLab tracks 6 FDA inspections and 1 compliance action at this facility.

What FDA found at this site

Latest inspection
Apr 15, 2025: No Action Indicated (NAI)
Inspections on record
6 (1 OAI, 2 VAI, 3 NAI)
Last OAI inspection
Oct 9, 2012
Warning letters
1 listed by FDA for this FEI, latest Mar 19, 2013

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Apr 15, 2025No Action Indicated (NAI)Quality audits - auditor independence (21 CFR 820.22)
Mar 8, 2018Voluntary Action Indicated (VAI)Quality audits - auditor independence (21 CFR 820.22)
Records of complaint investigation (21 CFR 820.198(e))
Dec 17, 2013No Action Indicated (NAI)No citations listed
Oct 9, 2012Official Action Indicated (OAI)DHR - not or inadequately maintained (21 CFR 820.184)
Procedures not adequately established or maintained (21 CFR 820.40)
Quality audits - auditor independence (21 CFR 820.22)
Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a))
and 4 more
Aug 17, 2011No Action Indicated (NAI)No citations listed
Aug 5, 2010Voluntary Action Indicated (VAI)Lack of or inadequate procedures - Acceptance activities (21 CFR 820.80(a))
DMR - not or inadequately maintained (21 CFR 820.181)

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
KMI IMI Group
Location
IRVINE, CA (US)
Source
device

Compliance actions

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.