Form 483

TRAFEROX TECHNOLOGIES INC Form 483, 2025-12-04

FDA issued a Form 483 to TRAFEROX TECHNOLOGIES INC on 2025-12-04 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

TRAFEROX TECHNOLOGIES INC · Mississauga, Canada · Issued December 4, 2025

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

4 Dec 2025
21 CFR 820.75(b)(2)

Documentation of validated process performance

Cited by Andrew J Garufi

Inspected site

TTTRAFEROX TECHNOLOGIES INCMississauga, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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