FDA 483 - Liuzhou LMZ Co., Ltd. - July 05, 2019

An FDA inspection of Liuzhou LMZ Co., Ltd., an OTC drug manufacturer in Liuzhou, Guangxi, China, from July 1-5, 2019, revealed significant deficiencies. The firm failed to establish and follow written procedures for manufacturing and quality control, exhibited inadequate laboratory controls and testing method verification, and maintained deficient records. These issues indicate a lack of adherence to good manufacturing practices.