483
Forsure Medical Products, LLCForsure Medical Products, LLC – FDA 483
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.
- Product type
- device
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ID · 0bfee43b-dfc3-4e5c-8a82-5ec4fd03cc91
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