DexCom Inc. has disclosed receiving a Warning Letter from the FDA following inspections at its San Diego and Mesa facilities. The letter cited non-conformities in manufacturing processes and quality management systems. DexCom assured that the warning does not restrict its ability to produce, market, or distribute its products, nor does it require a recall or prevent seeking FDA clearance for new products. Later, the FDA published details revealing that DexCom had modified components in its G6 and G7 glucose monitoring devices without prior regulatory approval, leading to concerns about device accuracy and potential health risks for users. These developments have led to significant declines in DexCom's stock price.