FDA-Inspected Site

Mardx Diagnostics Inc

5 FDA inspections are on record for Mardx Diagnostics Inc in Carlsbad, United States.

483· Form 483 issued

Carlsbad, United States · Last updated July 9, 2026

Overview

  • 5 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2019-01-10.

At a glance

Inspections

5

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Jan 2019 – 10 Jan 2019Medical Devices & Rad Health483On file
9 Jan 2018 – 11 Jan 2018Medical Devices & Rad Health483On file
30 Jan 2017 – 3 Feb 2017Medical Devices & Rad Health483On file
18 Sep 2013 – 19 Sep 2013Medical Devices & Rad HealthClean
6 Mar 2007Not recordedClean

Investigators

FDA investigators tied to this site in the record.

MDSAP WilliamsA2 insp.

Full site report

Get the verbatim findings behind Mardx Diagnostics Inc's 3 Form 483s

The full inspection record, as Atlas holds it, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat