FDA 483 - Ev Rider, LLC - March 05, 2019

An FDA inspection of Ev Rider, LLC in Fort Myers, FL, an initial importer and own label distributor of motorized mobility vehicles, revealed significant deficiencies in their quality system. The firm failed to establish adequate procedures for receiving, reviewing, and evaluating complaints, and also lacked written Medical Device Reporting (MDR) procedures. These issues indicate a failure to ensure proper handling of complaints and timely reporting of adverse events for their medical devices.