DexCom, Inc. received a warning letter from the U.S. Food and Drug Administration (FDA) on March 4, 2025, following inspections of its San Diego, California, and Mesa, Arizona facilities. The FDA cited deficiencies in DexCom’s response to previously issued Form 483 observations regarding non-conformities in manufacturing processes and quality management systems.

Despite the warning, the letter does not restrict DexCom’s ability to manufacture, market, or distribute its products, nor does it impact FDA 510(k) clearance of new products or require product recalls. DexCom has submitted multiple responses to the FDA and is preparing a formal reply to address the concerns. The company remains committed to implementing corrective actions and providing regular updates to the FDA.

DexCom does not expect this issue to have a material impact on its manufacturing capacity or its previously issued fiscal year 2025 revenue guidance. However, the company acknowledges the possibility of further regulatory action if the FDA is not satisfied with its corrective measures.