FDA 483 - Liuzhou Liangmianzhen (LMZ) Co., Ltd. - March 22, 2024

An FDA inspection of Liuzhou Liangmianzhen (LMZ) Co., LTD. in Liuzhou, China, an OTC drug manufacturer, identified significant deficiencies in laboratory controls, equipment maintenance, and environmental monitoring. The firm failed to implement scientifically sound testing procedures, maintain equipment and water systems properly, and establish adequate controls to prevent microbial contamination. These issues indicate a lack of adherence to good manufacturing practices, posing potential risks to drug product quality and safety.