Steris S.p.A. – FDA Inspection, Mar 5, 2026

Record Details

This FDA Inspection record concerns Steris S.p.A., with an inspection on March 5, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Steris S.p.A.
Inspection Date: March 5, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Scott D. Stevens (Issuing Officer)

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ID · 8560cb88-317a-4c90-b15c-a12f962818bb

Inspection Facts

Inspection number: 1306914
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.5.11Procedures for preserving the conformity of product not documented

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FDA Inspection

Steris S.p.A.March 5, 2026