Atlas

FDA-Inspected Site

Trimedyne Inc

4 FDA inspections are on record for Trimedyne Inc in Irvine, United States.

Clean· No action indicated

Irvine, United States · Last updated July 10, 2026

Overview

  • 4 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2019-03-21.

At a glance

Inspections

4

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Mar 2019Medical Devices & Rad HealthClean
23 Aug 2016 – 25 Aug 2016Medical Devices & Rad HealthClean
22 Jul 2011Not recorded483On file
10 Sep 2008Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Francis J Eng2 insp.
Leonard H Lavi1 insp.
James R Fleckenstein1 insp.

Full site report

Get the verbatim findings behind Trimedyne Inc's 1 Form 483

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