FDA 483 - Toyo Medical Co. - January 31, 2020

An FDA inspection of Toyo Medical Co. in Doral, FL, an importer/exporter/dealer/distributor of medical devices, revealed significant deficiencies in its quality system. The firm failed to establish written procedures for Medical Device Reporting (MDR), complaint handling, and corrective and preventive actions (CAPA). These omissions indicate a fundamental lack of control over critical quality processes.