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.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.