Cordis CorporationJanuary 12, 2018

FDA 483 - Cordis Corporation - January 12, 2018

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Record Details

An FDA inspection of Cordis Corporation in Milpitas, CA, revealed a significant issue regarding the timely reporting of unanticipated adverse device effects (UADEs). The firm failed to submit reports of suprarenal stent fractures to all reviewing IRBs and participating investigators within the required 10 working days. This constitutes a deviation from their investigational plan and regulatory expectations for device safety reporting.

Company: Cordis Corporation
Inspection Date: January 12, 2018
Product Type: Device
Office: Division of Human and Animal Food Operations - West V
Person: Dustin Tran (Investigator )

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ID · cd5e7d1c-e055-4312-ba9c-f694c946012e