FDA-Inspected Site

Arkray USA, Inc.

3 FDA inspections are on record for Arkray USA, Inc. in Edina, United States.

Clean· No action indicated

Edina, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2016-08-16.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Aug 2016 – 16 Aug 2016Medical Devices & Rad HealthClean
16 Oct 2012Not recordedClean
22 Jul 2011Not recorded483On file

Investigators

FDA investigators tied to this site in the record.

Full site report

Get the verbatim findings behind Arkray USA, 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