Safe Orthopaedics SAS – FDA Inspection, Mar 12, 2026

Record Details

This FDA Inspection record concerns Safe Orthopaedics SAS, with an inspection on March 12, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Safe Orthopaedics SAS
Inspection Date: March 12, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Wendy M. Stone (Company Rep)

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ID · de839d0e-255c-4b15-9ed7-c1910b963e6d

Inspection Facts

Inspection number: 1307086
FDA center: Medical Devices & Rad Health
Project area: Compliance: Medical Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented

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FDA Inspection

Safe Orthopaedics SASMarch 12, 2026