FDA 483 - Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co., Ltd - August 19, 2022

During an inspection of Hangzhou Zhongmeihuadong Pharmaceutical Jiangdong Co. Ltd, an Active Pharmaceutical Ingredient Manufacturer, an observation was made regarding the firm's quality unit procedures. Specifically, the firm failed to follow its own change control SOP by not initiating a change control for a specified test in a finished product validation test method. This indicates a lapse in adherence to established quality management processes.