By Sabela Ojea
DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response.
The diabetes devices maker on Friday said the warning letter doesn't restrict its ability to produce, market, manufacture or distribute products. It doesn't require the recall of any products either.
In the letter the FDA mentioned non-conformities in manufacturing processes and the quality management system, the company said in a filing with the Securities and Exchange Commission.
DexCom said it takes the matters identified seriously and intends to continue to undertake certain corrections and corrective actions.
"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 company said, adding that it can't give any assurances that the FDA will be satisfied with its response.
Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix
(END) Dow Jones Newswires
March 07, 2025 17:20 ET (22:20 GMT)
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