FDA 483 - Suzhou Homesun Pharmaceutical Co., Ltd. - April 12, 2019

An FDA inspection of Suzhou Homesun Pharmaceutical Co. Ltd. in Jiangsu, P.R. China, revealed numerous deficiencies in their manufacturing of active pharmaceutical ingredients (APIs). The firm was cited for poor facility and equipment maintenance, inadequate material identification and storage, and significant gaps in documentation for critical operations, laboratory testing, and quality reviews. These issues indicate a lack of adherence to good manufacturing practices and robust quality control systems.