Novum Medical Products of NY, LLCDecember 5, 2023

FDA 483 - Novum Medical Products of NY, LLC - December 05, 2023

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Record Details

Novum Medical Products of NY, LLC, a medical device manufacturer in Amherst, NY, received a Form FDA 483 with one repeat observation. The inspection revealed inadequacies in the firm's corrective and preventive action (CAPA) procedures, specifically concerning the verification of effectiveness and comprehensive issue resolution. This indicates a persistent issue with their quality system.

Company: Novum Medical Products of NY, LLC
Inspection Date: December 5, 2023
Product Type: Device
Office: Division of Human and Animal Food Operations - East I
Person: Matthew D. Schnittker

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ID · f2f93b93-43fc-4baa-9682-4e6f3d2efbcc