Forsure Medical Products, LLC

FDA 483 - Forsure Medical Products, LLC

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Record Details

An FDA inspection of Forsure Medical Products, LLC in Doral, FL, conducted in August 2023, identified a significant issue regarding the firm's complaint handling system. The company failed to maintain complaint files and properly implement its product complaint handling procedure, leading to inadequate processing, review, evaluation, and investigation of device-related complaints. This indicates a breakdown in critical quality system controls for medical devices.

Company: Forsure Medical Products, LLC
Product Type: Device
Office: Office of Medical Device and Radiological Health Division II
Person: Gisselle I. Sensebe

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ID · 0bfee43b-dfc3-4e5c-8a82-5ec4fd03cc91