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 July 10, 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 Health483On file
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.

Benjamin J Dastoli2 insp.
Suyang Qin1 insp.
Roy Baby1 insp.
Wanda J Torres1 insp.

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

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