Philips received data from a variety of sources regarding degradation of the PE-PUR foam contained within the recalled devices, including complaints, test reports, information from suppliers, and information from another entity owned by Philips’s parent company. According to the FDA, Philips “failed to adequately evaluate this data and incorporate it into its CAPA (Corrective and Preventative Actions) system for further investigation and potential mitigation, as required by current good manufacturing practice requirements.”