Atlas

Form 483

UNOX SPA Form 483, 2025-05-13

FDA issued a Form 483 to UNOX SPA on 2025-05-13 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

UNOX SPA · Cadoneghe, Italy · Issued May 13, 2025

Overview

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

Inspectional observations

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

13 May 2025
21 CFR 1010.2(c)

Certification not based on adequate test/testing program

Cited by Gregory M Bessette, Fouad Attioui

13 May 2025
21 CFR 1030.10(c)(3)(i)

tests--errors and uncertainties accounted for

Cited by Gregory M Bessette, Fouad Attioui

Inspected site

USUNOX SPACadoneghe, Italy

Inspection team

GMGregory M Bessette
FAFouad Attioui

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1010.2(c)Cited across public-safe Form 483 observations1x
21 CFR 1030.10(c)(3)(i)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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