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MCKEON PRODUCTS, INC. — FDA Facility Profile

FEI 1818945

MCKEON PRODUCTS, INC. is an FDA-registered facility (FEI 1818945) located in WARREN, MI, US. RegDataLab tracks 2 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 7, 2025: Voluntary Action Indicated (VAI)
Inspections on record
2 (1 VAI, 1 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

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
May 7, 2025Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Lack of or inadequate procedures (21 CFR 820.100(a))
Lack of Written MDR Procedures (21 CFR 803.17)
Apr 11, 2018No Action Indicated (NAI)No citations listed

Facility details

Company
McKeon Products, Inc.
Location
WARREN, MI (US)
Source
device

FDA data resources

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