FDA-Inspected Site

CareFusion DR 203 LTD

5 FDA inspections are on record for CareFusion DR 203 LTD in Santo Domingo, Dominican Republic (the).

Clean· No action indicated

Santo Domingo, Dominican Republic (the) · Last updated August 15, 2026

Overview

  • 5 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-09-18.

At a glance

Inspections

5

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Sep 2025 – 18 Sep 2025Medical Devices & Rad HealthClean
22 Oct 2018 – 25 Oct 2018Medical Devices & Rad HealthClean
2 May 2016 – 5 May 2016Medical Devices & Rad Health483View 483 →
27 Oct 2014 – 30 Oct 2014Medical Devices & Rad HealthClean
18 Sep 2008Not recordedClean

Observations on record

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

5 May 2016
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Roy Baby

5 May 2016
21 CFR 820.75(b)

Lack/Inad procedure-Monitoring/Control of Validated Proces

Cited by Roy Baby

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.70(c)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind CareFusion DR 203 LTD's 1 Form 483

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