FDA 483 - Dot International - March 05, 2020

Dot International, a manufacturer of Class II reusable menstrual cup devices in Evanston, IL, received a Form FDA 483 with seven observations, including repeat findings for design validation, CAPA, and complaint handling. The inspection revealed significant deficiencies in design controls, supplier management, complaint handling, and device history records, indicating a systemic lack of established and followed quality system procedures. A serious customer complaint involving illness was also not properly investigated or evaluated for MDR reportability.