FDA 483 - Koya Medical, Inc - October 24, 2025

Koya Medical, Inc. in Dallas, TX, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to properly assess the reportability of adverse events, including electric shocks and burns, which may be Medical Device Report (MDR) reportable. The evaluation process lacked necessary assessments and contradicted its own risk management definitions for serious injuries.