483
Zoll Medical CorporationZoll Medical Corporation – FDA 483, Jan 26, 2024
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
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