FDA 483 - Onyx Medical, LLC - February 13, 2026

Onyx Medical, LLC dba Elos Medtech, a contract manufacturing facility in Bartlett, TN, was cited for failing to adequately apply a risk-based approach to its quality management system. The inspection revealed deficiencies in applying risk-based controls to quality data analysis, management review processes, and decision-making for critical manufacturing changes. These issues limited management's ability to identify systemic problems and ensure QMS effectiveness, potentially impacting product quality.