FDA 483 - Foremount Enterprise Co., Ltd. - June 19, 2025

Foremount Enterprise Co., Ltd. in Taichung City, Taiwan, a medical device manufacturer, was cited with nine observations during an FDA inspection. The inspection revealed significant deficiencies across multiple quality system areas, including lack of unique device identifiers, inadequate complaint handling and MDR procedures, unvalidated processes, and insufficient CAPA, acceptance, DHR, and personnel training. These issues indicate a broad failure to comply with FDA regulations for medical devices intended for the US market.