STERIS AST CZ s.r.o. – FDA Inspection, Apr 29, 2026

Record Details

This FDA Inspection record concerns STERIS AST CZ s.r.o., with an inspection on April 29, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.

Company: STERIS AST CZ s.r.o.
Inspection Date: April 29, 2026
Product Type: Medical Devices & Rad Health
Office: Office of Inspections and Investigations
Person: John A. Sciacchitano (Company Rep)

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ID · d7835638-8c2e-4211-aebb-37ff5ee33756

Inspection Facts

Inspection number: 1314542
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented

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FDA Inspection

STERIS AST CZ s.r.o.April 29, 2026