FDA issues warning to Dexcom
By HME News Staff
Updated 10:08 AM CDT, Thu March 27, 2025
SAN DIEGO – Dexcom has received a warning letter from the U.S. Food and Drug Administration regarding “non-conformities” in manufacturing and quality processes after inspections of its facilities in Sad Diego and Mesa, Ariz. In a form 8-K filed with the U.S. Securities and Exchange Commission, the company said it takes the matters identified in the warning letter seriously, has already submitted several responses to Form 483 and is in the process of preparing a written response to the warning letter. Dexcom will continue to undertake certain corrections and corrective actions and will also continue to provide regular updates to the FDA. 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, it stated. 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. 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.
Comments