Atlas

Form 483

SPITREX ORTHOPEDICS SWITZERLAND SA Form 483, 2026-05-07

FDA issued a Form 483 to SPITREX ORTHOPEDICS SWITZERLAND SA on 2026-05-07 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

SPITREX ORTHOPEDICS SWITZERLAND SA · Le Locle, Switzerland · Issued May 7, 2026

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

7 May 2026
ISO 13485:2016 Clause 7.1

Records of risk management activities in product realization not maintained

Cited by John A Sciacchitano

7 May 2026
ISO 13485:2016 Clause 8.2.2

Complaint handling procedures not documented

Cited by John A Sciacchitano

7 May 2026
ISO 13485:2016 Clause 8.5.2

Corrective action procedures not documented

Cited by John A Sciacchitano

Inspected site

SOSPITREX ORTHOPEDICS SWITZERLAND SALe Locle, Switzerland

Inspection team

JAJohn A Sciacchitano

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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