FDA-Inspected Site

JW North America, Inc.

4 FDA inspections are on record for JW North America, Inc. in Rockland, United States.

Clean· No action indicated

Rockland, United States · Last updated July 9, 2026

Overview

  • 4 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-12-04.

At a glance

Inspections

4

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
3 Dec 2025 – 4 Dec 2025Medical Devices & Rad HealthClean
18 Jun 2019 – 20 Jun 2019Medical Devices & Rad Health483View 483 →
21 Sep 2017 – 22 Sep 2017Medical Devices & Rad Health483View 483 →
15 Sep 2015 – 21 Sep 2015Medical Devices & Rad Health483View 483 →

Observations on record

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

20 Jun 2019
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Nabil Nakhoul

20 Jun 2019
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Nabil Nakhoul

20 Jun 2019
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Nabil Nakhoul

20 Jun 2019
21 CFR 820.100(b)

Documentation

Cited by Nabil Nakhoul

20 Jun 2019
21 CFR 820.100(b)

Documentation

Cited by Nabil Nakhoul

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 820.22Cited across public-safe Form 483 observations6x
21 CFR 803.17Cited across public-safe Form 483 observations3x
21 CFR 820.100(b)Cited across public-safe Form 483 observations3x
21 CFR 820.30(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50(a)(2)Cited across public-safe Form 483 observations3x
21 CFR 820.20(e)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind JW North America, Inc.'s 3 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