Redicare LLCJanuary 10, 2025

FDA 483 - Redicare LLC - January 10, 2025

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An FDA inspection of Redicare LLC, a medical device manufacturer and importer in Congers, NY, revealed a significant compliance issue. The firm failed to maintain written Medical Device Reporting (MDR) procedures and did not register for the FDA's Electronic Submissions Gateway (ESG) system. This indicates a critical deficiency in their system for reporting serious adverse events related to medical devices.

Company: Redicare LLC
Inspection Date: January 10, 2025
Product Type: Device
Office: New York District Office
Person: Kwong P. Lee (investigator)

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ID · 8f9398e5-79e7-4edd-bae7-1c87b281a7d1