DexCom, Inc. announced that it received a warning letter from the U.S. Food and Drug Administration following inspections of its facilities in San Diego, California, and Mesa, Arizona. The letter cited deficiencies in the company’s response to previously identified observations regarding manufacturing processes and quality management systems. The warning does not impact the company’s ability to produce, market, or distribute products, nor does it require a recall. DexCom has submitted multiple responses to the FDA and is working on further corrective actions. The company does not expect the letter to affect its manufacturing capacity or its previously issued 2025 revenue guidance.
Value Investor
2025-03-10
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