FDA 483 - Shanghai SynTheAll Pharmaceutical Co., Ltd. - November 30, 2018

During an inspection of STA Pharmaceutical Co., Ltd. in Jinshan District, Shanghai, FDA investigators observed a significant quality control issue. A critical study to determine the potential of a starting material used in API manufacture was not completed until after the API had already been manufactured and distributed for Phase clinical trials. The study ultimately concluded the material was a weak substance, indicating a potential risk to product quality and patient safety.