483
Zoll Medical CorporationFDA 483 - Zoll Medical Corporation - January 26, 2024
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Record Details
Zoll Medical Corporation in Bothell, WA, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in the firm's quality system, specifically concerning corrective and preventive actions, complaint handling procedures, and the maintenance of device history records. These issues indicate a need for improved adherence to regulatory requirements for medical device manufacturing.
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ID · 16d96573-dcb4-4669-9b08-8b69ac901a83