FDA-Inspected Site

Joylux, Inc.

1 FDA inspection is on record for Joylux, Inc. in Seattle, United States.

483· Form 483 issued

Seattle, United States · Last updated August 15, 2026

Overview

  • 1 FDA inspection is on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-15.

At a glance

Inspections

1

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
10 Jun 2026 – 15 Jun 2026Medical Devices & Rad Health483View 483 →

Observations on record

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

15 Jun 2026
21 CFR 801.40(a)

Form of a unique device identifier

Cited by Brian R Hendricks

15 Jun 2026
21 CFR 801.40(a)

Form of a unique device identifier

Cited by Brian R Hendricks

15 Jun 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling procedures not documented

Cited by Brian R Hendricks

15 Jun 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling procedures not documented

Cited by Brian R Hendricks

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 801.40(a)Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Joylux, Inc.'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