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483
•ZOLL Medical Corporation•July 24, 2025

FDA 483 - ZOLL Medical Corporation - July 24, 2025

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Record Details

An FDA inspection of ZOLL Medical Corporation in Wilmington, MA, revealed deficiencies in the firm's personnel training procedures. Specifically, the company failed to adequately identify training needs, leading to critical personnel lacking required training for their assigned responsibilities, such as incoming inspection and corrective and preventive actions. This indicates a significant lapse in the firm's quality system management.

Company
ZOLL Medical Corporation
Inspection Date
July 24, 2025
Product Type
Device
Office
New England District Office
Person
  • James P. Finn (investigator)
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ID · df6d7c56-85bf-46fe-8a89-ab896571e53b

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