Form 483

Cadex Electronics Inc. Form 483, 2026-01-09

FDA issued a Form 483 to Cadex Electronics Inc. on 2026-01-09 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Cadex Electronics Inc. · Richmond, Canada · Issued January 9, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

9 Jan 2026
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Thai T Duong

9 Jan 2026
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Thai T Duong

9 Jan 2026
21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Thai T Duong

9 Jan 2026
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Thai T Duong

Inspected site

CECadex Electronics Inc.Richmond, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.120Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x

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