FDA 483 - Yabao Pharmaceutical Co., Ltd. Beijing - April 20, 2022

An FDA inspection of Yabao Pharmaceutical Co., Ltd. in Beijing, P. R. China, revealed significant deficiencies in equipment qualification and quality control unit procedures. The firm failed to adhere to its own written procedures for equipment calibration and performance qualification. Additionally, issues were noted in stability studies, impurity reporting, and the thoroughness of investigations into out-of-trend and abnormal data.