FDA 483 - Myron L Company - September 19, 2025

Myron L Company, a medical device manufacturer in Carlsbad, CA, was cited for significant deficiencies in its complaint handling system. The firm failed to establish and maintain adequate procedures for receiving, reviewing, and evaluating complaints, instead processing device malfunctions through a "Repair Service Order" system that bypassed regulatory requirements. This indicates a serious lack of control over product quality and potential risks related to uninvestigated device failures and unreported events.