FDA-Inspected Site

Truer Medical Inc

7 FDA inspections are on record for Truer Medical Inc in Orange, United States.

483· Form 483 issued

Orange, United States · Last updated July 11, 2026

Overview

  • 7 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-02-13.

At a glance

Inspections

7

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Feb 2026 – 13 Feb 2026Medical Devices & Rad Health483View 483 →
28 Jun 2023Medical Devices & Rad HealthClean
19 Feb 2020 – 20 Feb 2020Medical Devices & Rad HealthClean
10 Jul 2014 – 15 Jul 2014Medical Devices & Rad HealthClean
13 Aug 2008Not recordedClean
7 Jun 2006Not recordedClean
23 Dec 2003Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

13 Feb 2026
ISO 13485:2016 Clause 7.3.10

Design and development files not maintained

Cited by Jordan I Abel

13 Feb 2026
ISO 13485:2016 Clause 7.3.10

Design and development files not maintained

Cited by Jordan I Abel

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.3.10Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Truer Medical Inc's 1 Form 483

Recurring CFR citations, 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