DexCom said it received a warning letter from the U.S. Food and Drug Administration on March 4, 2025 following inspections of its San Diego, California, and Mesa, Arizona facilities.

1. 01

   DexCom said it received a warning letter from the U.S. Food and Drug Administration on March 4, 2025 following inspections of its San Diego, California, and Mesa, Arizona facilities.

2. 02

   DexCom said the FDA cited deficiencies in its responses to the Form 483 for the San Diego facility inspection from October 21, 2024 to November 7 and the Mesa facility inspection from June 10, 2024 to 14.

3. 03

   The company said the warning letter does not restrict its ability to produce, market, manufacture or distribute products, and does not require any product recall. The company also said it does not expect a material impact on its manufacturing capacity or on the revenue guidance it issued on February 13, 2025.

4. 04

   The company said it has already responded several times to the Form 483 and is preparing a written response to the warning letter. It also said it cannot give assurances that the FDA will be satisfied with its response or as to when the matters will be resolved, and that additional legal or regulatory action may be taken without further notice until the issues are resolved to the FDA's satisfaction.

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Original filing

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