DexCom Gets Warning Letter From FDA Following Inspections

DexCom received a warning letter from the FDA following inspections of its facilities in San Diego, California, and Mesa, Arizona.

• Doesn’t expect material impact on its manufacturing capacity or fy25 revenue guidance
• FDA observed non-conformities in manufacturing processes and quality management system during 2024 inspections
• Letter does not restrict DexCom’s ability to produce, market, manufacture or distribute products
• Does not require recall of any products nor restrict ability to seek FDA clearance of new products
• DexCom has already submitted several responses and is preparing a written response to the warning letter
• Additional legal or regulatory action may be taken by ...