FDA 483 - Shandong Anshun Pharmaceutical Co., Ltd. - November 16, 2020

An FDA inspection of Shandong Anshun Pharmaceutical Co., Ltd., an API manufacturer in China, revealed significant issues with their quality control systems. The firm failed to follow its written stability program, resulting in stability tests not being performed by their planned due dates. Additionally, analysts in the QC Laboratory were found to be inadequately trained on analytical methods, leading to out-of-specification results due to analyst error.