Dexcom Receives FDA Warning Letter Over Manufacturing Issues

Dexcom has received an FDA warning letter citing non-conformities in manufacturing processes and quality management systems at its facilities in Arizona and California. The letter follows FDA inspections in 2024, which led to Form 483 observations. Despite this, Dexcom does not anticipate any major impact on its manufacturing, sales, or regulatory approvals. Analysts believe the company will resolve the issues without significant operational disruption, and Dexcom has already implemented process improvements in response.

While Dexcom is preparing a response to the FDA, the company acknowledges that it cannot guarantee regulatory satisfaction or a resolution timeline. The FDA retains the right to take further action until the concerns are addressed. Despite historical cases where warning letters have led to increased compliance costs for medtech firms, analysts do not expect this issue to significantly affect Dexcom’s financial outlook or ongoing product approvals, including its anticipated 15-day sensor.