InSightec, Ltd.November 30, 2017

FDA 483 - InSightec, Ltd. - November 30, 2017

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Record Details

InSightec, Ltd., a medical device manufacturer in Tirat Carmel, Hefa, Israel, received two observations during an FDA inspection. The firm's medical device reporting (MDR) procedure was found to be inadequate, leading to a failure to report two serious injury events. Additionally, their corrective and preventive action (CAPA) procedures were not adequately established, specifically lacking verification of effectiveness.

Company: InSightec, Ltd.
Inspection Date: November 30, 2017
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
People: Leonard H. Lavi (Investigative Engineer )
Rosanna M. Goodrich (Medical Device Specialist)

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ID · 710b939e-448c-4a8d-a00d-9d8319e69724