FDA 483 - Redicare LLC - January 10, 2025

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.