Atlas

FDA-Inspected Site

Mindray DS USA, Inc. dba Mindray North America

10 FDA inspections are on record for Mindray DS USA, Inc. dba Mindray North America in Mahwah, United States.

Clean· No action indicated

Mahwah, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-02-22.

At a glance

Inspections

10

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
15 Feb 2024 – 22 Feb 2024Medical Devices & Rad HealthClean
2 Apr 2018 – 20 Apr 2018Medical Devices & Rad HealthClean
8 Mar 2016 – 31 Mar 2016Medical Devices & Rad Health483View 483 →
22 Jan 2015 – 10 Mar 2015Medical Devices & Rad Health483View 483 →
10 Jul 2013 – 23 Sep 2013Medical Devices & Rad Health483On file
2 Aug 2012Not recordedWLView 483 →
10 Jun 2010Not recorded483On file
8 Jul 2008Not recorded483On file
19 Mar 2004Not recordedClean
20 Aug 2001Not recordedClean

Observations on record

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

31 Mar 2016
21 CFR 820.198(c)

Investigation of device failures

Cited by Li Li

31 Mar 2016
21 CFR 820.198(c)

Investigation of device failures

Cited by Li Li

10 Mar 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by David H Smith

10 Mar 2015
21 CFR 820.72(a)

Equipment suitability & capability

Cited by David H Smith

10 Mar 2015
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by David H Smith

Investigators

FDA investigators tied to this site in the record.

Li Li3 insp.
David H Smith2 insp.
Robert G Ruff2 insp.
Melissa A Zuppe1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.198(c)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x
21 CFR 820.90(a)Cited across public-safe Form 483 observations2x
21 CFR 803.17(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.30(h)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.86Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Mindray DS USA, Inc. dba Mindray North America's 6 Form 483s

Source PDFs, 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