FDA-Inspected Site

Atos Medical AB

3 FDA inspections are on record for Atos Medical AB in Horby, Sweden.

483· Form 483 issued

Horby, Sweden · 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 2017-09-22.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Sep 2017 – 22 Sep 2017Medical Devices & Rad Health483On file
9 Sep 2013 – 12 Sep 2013Medical Devices & Rad HealthClean
24 Mar 2011Not recordedClean

Investigators

FDA investigators tied to this site in the record.

MDSAP harperd1 insp.

Full site report

Get the verbatim findings behind Atos Medical AB'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