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Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the manufacture of finished pharmaceutical drugs following an FDA inspection in March 2024. The company limited and refused FDA inspection access, particularly by restricting access to manufacturing records including process validation reports and batch production records, which constitutes drug adulteration under the Federal Food, Drug, and Cosmetic Act. These inspection obstruction actions, combined with non-conforming manufacturing methods, facilities, and controls, resulted in the company's drug products being deemed adulterated and unfit for distribution.