FDA 483 - Beijing Xinggu Lvsan Technology Co., Ltd - April 11, 2022

An FDA inspection of Beijing Lvsan Technology Co., Ltd., a drug manufacturer in Pinggu District, Beijing, revealed significant deficiencies in their quality control unit, data management, and manufacturing processes for hand sanitizers intended for the US market. The firm failed to establish written procedures, validate processes and equipment, perform adequate testing on raw materials and finished products, and maintain proper batch records. These issues indicate a severe lack of adherence to Good Manufacturing Practices.