Following inspections, Dexcom, a medical device manufacturer, has received warnings from the Food and Drug Administration (FDA) at two of its manufacturing facilities, its headquarters in San Diego, California and its facility in Mesa, Arizona. The letters indicate that manufacturing processes and quality management systems at the facilities exhibited issues, though the company does not “expect a material impact” on its manufacturing capacity or sales guidance for the 2025 fiscal year.
Dexcom has already submitted its responses to Form 483, which is an agency report that indicates observations that the FDA “deem to be objectionable.” Shares of the company fell nearly seven percent after news of the warnings broke.
