FDA 483 - Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. - March 22, 2024

TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. in Tianjin, China, was inspected and received five observations related to significant deficiencies in their manufacturing and quality control processes. The firm lacked adequate written procedures for production and process controls, failed to manage changes effectively, had insufficient laboratory controls including data review and impurity testing, and maintained unclean equipment. These issues indicate a lack of robust quality systems to ensure drug product identity, strength, quality, and purity.