Atlas

Form 483

Steris S.p.A. Form 483, 2026-02-26

FDA issued a Form 483 to Steris S.p.A. on 2026-02-26 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Steris S.p.A. · Seriate, Italy · Issued February 26, 2026

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.

26 Feb 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Scott D Stevens

Inspected site

SSSteris S.p.A.Seriate, Italy

Inspection team

SDScott D Stevens

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.2Cited 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