DexCom receives warning letter from FDA, sees no impact to FY25 guidance

In a regulatory filing, DexCom (DXCM) disclosed that on March 4, the company received a warning letter from the U.S. FDA following inspections of the company’s facilities in San Diego, California, and Mesa, Arizona. In the warning letter, the FDA cited deficiencies in the response letters sent by the company to the FDA following the Form 483, List of Investigational Observations, which was delivered to the company in connection with the inspection of the San Diego facility that occurred from October 21, 2024 through November 7, 2024, and the inspection of the Mesa, Arizona facility that occurred from June 10, 2024 through June 14, 2024. The warning letter describes observed non-conformities in manufacturing processes and quality management system. The warning letter does not restrict the company’s ability to produce, market, manufacture or distribute products, require recall of any products, nor restrict the company’s ability to seek FDA 510(k) clearance of new products. The company takes the matters identified in the warning letter seriously, has already submitted several responses to the Form 483 and is in the process of preparing a written response to the warning letter. The company intends to continue to undertake certain corrections and corrective actions and will also continue to provide regular updates to the FDA in response to the Form 483. The company cannot, however, give any assurances that the FDA will be satisfied with its response or as to the expected date of the resolution of the matters included in the warning letter. Until the issues cited in the warning letter are resolved to the FDA’s satisfaction, additional legal or regulatory action may be taken without further notice. DexCom does not expect a material impact from the warning letter described above to the company’s manufacturing capacity or the fiscal year 2025 guidance for revenue previously issued on February 13.