DexCom (DXCM) said late Friday it was notified earlier this week by the US Food and Drug Administration that its facilities in Mesa, Arizona, and San Diego were found to have non-conformities in manufacturing processes and quality management system during inspections last year.
The warning letter will not restrict its ability to produce, market, manufacture or distribute products nor will it require DexCom to recall any products, the company said in a filing with the US Securities and Exchange Commission.
DexCom also said it does not expect the regulatory notice to have a material impact on its operations or financial guidance for fiscal 2025.
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