FDA 483 - Hi-Dow International Inc - December 05, 2019

Hi-Dow International Inc., a specification developer, complaint handling establishment, and initial importer of medical devices, was cited for severe deficiencies in its quality system. The inspection revealed a systemic failure to establish and implement critical procedures, including complaint handling, design control, supplier management, software validation, acceptance activities, CAPA, management reviews, and quality audits. Many of these issues are repeat observations from previous inspections, indicating a persistent lack of compliance.