FDA 483 - DMD Medical Group - August 25, 2021

DMD Medical Group, an initial import/distributor in Chesterfield, SC, was inspected by the FDA, revealing significant deficiencies in their quality system. The inspection found a complete absence of written procedures for critical functions including complaint handling, medical device reporting (MDRs), and corrective and preventive actions (CAPA). These findings indicate a fundamental lack of established processes for managing product quality and safety.