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INMEDIX, INC. — FDA Facility Profile

FEI 3036039911

INMEDIX, INC. is an FDA-registered facility (FEI 3036039911) located in Normandy Park, WA, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 20, 2026: Voluntary Action Indicated (VAI)
Inspections on record
1 (1 VAI)
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
Mar 20, 2026Voluntary Action Indicated (VAI)Management review procedures not documented (ISO 13485:2016 Clause 5.6.1)
Design and development validation not performed as planned (ISO 13485:2016 Clause 7.3.7)
Complaint handling procedures not documented (ISO 13485:2016 Clause 8.2.2)

Facility details

Company
Inmedix, Inc.
Location
Normandy Park, WA (US)
Source
device

FDA data resources

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