Dexcom Receives FDA Warning Letter Over Manufacturing Issues

Dexcom disclosed receiving an FDA warning letter on March 4, citing manufacturing and quality management issues at its Arizona and California facilities. While the FDA has yet to publish the letter, Dexcom stated it does not expect a significant impact on production, sales, or new product clearances.

FDA inspections at the Mesa, AZ (June) and San Diego, CA (October–November) facilities led to a Form 483, highlighting concerns that Dexcom addressed in multiple responses. However, the FDA deemed the responses inadequate, leading to the warning letter.

Dexcom has already implemented process controls and is preparing a response. While the company anticipates no major financial impact, it acknowledges uncertainty regarding the FDA’s satisfaction with its corrective actions. The agency retains the right to take further regulatory or legal actions if issues remain unresolved.

13-03-2025

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