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

Beijing Lvsan Technology Co., Ltd., a drug manufacturer in Pinggu District, Beijing, CN, was cited for significant deficiencies across its quality control unit, laboratory operations, and manufacturing processes. The inspection revealed issues including inadequate data backup, lack of component identification testing, absence of a stability study program, and unvalidated manufacturing processes for OTC hand sanitizers. Additionally, the firm failed to establish written cleaning procedures for non-dedicated equipment and lacked proper qualification for manufacturing equipment and laboratory controls.