Atlas

Form 483

Lumitex Medical Devices Inc Form 483, 2026-05-01

FDA issued a Form 483 to Lumitex Medical Devices Inc on 2026-05-01 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Lumitex Medical Devices Inc · Brecksville, United States · Issued May 1, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

1 May 2026
ISO 13485:2016 Clause 4.1.5

Control over outsourced processes not proportionate to risk

Cited by Javonica F Penn

1 May 2026
ISO 13485:2016 Clause 4.1.5

Control over outsourced processes not proportionate to risk

Cited by Javonica F Penn

1 May 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling procedures not documented

Cited by Javonica F Penn

1 May 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling procedures not documented

Cited by Javonica F Penn

Inspected site

LMLumitex Medical Devices IncBrecksville, United States

Inspection team

JFJavonica F Penn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.5Cited across public-safe Form 483 observations2x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere