Steris CorporationMarch 31, 2022

FDA 483 - Steris Corporation - March 31, 2022

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Record Details

An FDA inspection of Carefusion 2200 Inc in Saint Louis, MO, revealed a significant lapse in quality system procedures. The firm failed to establish procedures for finished device acceptance, leading to products not being properly identified or quarantined. This indicates a moderate compliance issue related to device control.

Company: Steris Corporation
Inspection Date: March 31, 2022
Product Type: Device
Office: Division of Human and Animal Food Operations - West II
Person: Clifford F. Long

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ID · 9ae203c3-7b01-4f91-8c77-9527180af18d