FDA 483 - Shandong Luxi Pharmaceutical Co., Ltd. - July 24, 2019

An FDA inspection of Shandong Luxi Pharmaceutical Co. Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Heze City, China, revealed significant deficiencies in laboratory controls and data integrity. Observations included insufficient stability studies, inadequate maintenance of laboratory records and raw data, and a lack of proper procedures for electronic data review and system validation. These findings indicate a serious breakdown in the firm's quality control systems.