FDA 483 - Hangzhou AGS Meditech Co., Ltd. - May 02, 2019

An FDA inspection of Hangzhou AGS MedTech Co. Ltd. in Hangzhou, China, revealed significant deficiencies in the firm's quality system. Observations included inadequate procedures for the rework of non-conforming products and a failure to adequately establish CAPA procedures, resulting in continued product complaints without verified corrective actions.