FDA-Inspected Site

Nihon Kohden Digital Health Solutions, LLC.

6 FDA inspections are on record for Nihon Kohden Digital Health Solutions, LLC. in Irvine, United States.

Clean· No action indicated

Irvine, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 0 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-24.

At a glance

Inspections

6

Form 483s

0

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Feb 2026 – 24 Feb 2026Medical Devices & Rad HealthClean
13 Jun 2023Medical Devices & Rad HealthClean
12 May 2016 – 13 May 2016Medical Devices & Rad HealthClean
5 Aug 2011Not recordedClean
18 Sep 2002Not recordedClean
20 Oct 2000Not recordedClean

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Nihon Kohden Digital Health Solutions, LLC.'s inspection record

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