FDA 483 - Wintech Medipro LLC - July 06, 2022

Wintech Medipro LLC, a manufacturer of Class 2 surgical masks in Katy, TX, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to establish fundamental procedures across nearly all critical areas of medical device manufacturing, including complaint handling, MDRs, design control, CAPA, and process validation. This indicates a severe lack of a compliant quality management system.