FDA 483 - Wintech Medipro LLC - May 22, 2023

Wintech Medipro LLC, a manufacturer of Class II surgical masks in Katy, TX, was cited with 13 observations during an FDA inspection. The firm has failed to establish numerous critical quality system procedures, including those for quality systems, complaint handling, MDRs, design control, process validation, acceptance activities, CAPA, nonconforming product, supplier evaluation, equipment maintenance, quality audits, management review, and training. Many of these issues were repeat observations from a previous 2022 inspection, indicating a severe and persistent lack of compliance with FDA regulations for medical devices.