Atlas

FDA-Inspected Site

Douglas Medical Products, Inc.

3 FDA inspections are on record for Douglas Medical Products, Inc. in Mundelein, United States.

483· Form 483 issued

Mundelein, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-24.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
16 Jun 2026 – 24 Jun 2026Medical Devices & Rad Health483View 483 →
14 Dec 2021Medical Devices & Rad HealthClean
19 Sep 2017 – 21 Sep 2017Medical Devices & Rad Health483View 483 →

Observations on record

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

24 Jun 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Natasha R Johnson, Shuana H Xiong

24 Jun 2026
ISO 13485:2016 Clause 7.3.9

Procedures to control design and development changes not documented

Cited by Natasha R Johnson, Shuana H Xiong

24 Jun 2026
ISO 13485:2016 Clause 7.4.1

Records of supplier (re)evaluation, selection, and monitoring not maintained

Cited by Natasha R Johnson, Shuana H Xiong

24 Jun 2026
ISO 13485:2016 Clause 8.5.2

Corrective action not taken

Cited by Natasha R Johnson, Shuana H Xiong

21 Sep 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jesse A Vazquez

Investigators

FDA investigators tied to this site in the record.

Natasha R Johnson2 insp.
Shuana H Xiong1 insp.
Jesse A Vazquez1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.9Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Douglas Medical Products, Inc.'s 2 Form 483s

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