FDA-Inspected Site

Siemens Healthineers Ltd.

2 FDA inspections are on record for Siemens Healthineers Ltd. in Seongnam, Korea (the Republic of).

Clean· No action indicated

Seongnam, Korea (the Republic of) · Last updated July 10, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2017-03-17.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Mar 2017 – 17 Mar 2017Medical Devices & Rad HealthClean
21 Sep 2012Not recorded483View 483 →

Observations on record

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

21 Sep 2012
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Christine M Parmentier

Investigators

FDA investigators tied to this site in the record.

MDSAP WilliamsA1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Siemens Healthineers Ltd.'s 1 Form 483

Verbatim observations and 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