Steris Italy S.R.L. – FDA Inspection, Jul 30, 2026

Record Details

This FDA Inspection record concerns Steris Italy S.R.L., with an inspection on July 30, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: Steris Italy S.R.L.
Inspection Date: July 30, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: Ulysses D. Singleton (Issuing Officer)

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ID · fab729f0-8333-4463-86ed-45c03015c986

Inspection Facts

Inspection number: 1330798
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 8.5.3Preventive action procedures not documented

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FDA Inspection

Steris Italy S.R.L.July 30, 2026