The letter comes after FDA inspections conducted in mid-2024 and late 2024, citing deficiencies in the company’s responses to previous observations, according to a Securities and Exchange Commission filing.
Despite the warning letter, Dexcom said in the filing it does not anticipate a material impact on manufacturing capacity or 2025 revenue.
The FDA notice does not limit the company’s ability to manufacture, market or distribute products, the filing said.
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