FDA 483 - Dexcom, Inc.

Dexcom, Inc. received a Form FDA-483 following an inspection of its San Diego facility from October 21 to November 7, 2024. The company is committed to addressing the identified concerns, which relate to quality management system processes, manufacturing controls, and product performance for its continuous glucose monitoring devices. Dexcom has outlined immediate actions and ongoing commitments to drive improvements across its manufacturing sites.