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TriRx Medical, LLC — FDA Facility Profile

FEI 3027390974

TriRx Medical, LLC is an FDA-inspected facility (FEI 3027390974) located in Naples, FL, US. RegDataLab tracks 1 FDA inspection at this facility.

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What FDA found at this site

Latest inspection
Mar 6, 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 6, 2026Voluntary Action Indicated (VAI)Risk-based approach not applied to QMS processes (ISO 13485:2016 Clause 4.1.2)
Process for production and service provision not validated (ISO 13485:2016 Clause 7.5.6)
Evidence of conformity to the acceptance criteria not maintained (ISO 13485:2016 Clause 8.2.6)
Records of nonconforming product and actions taken not maintained (ISO 13485:2016 Clause 8.3.1)

Facility details

Company
TriRx Medical, LLC
Location
Naples, FL (US)
Source
inspections

FDA data resources

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