FDA 483 - Lonza Guangzhou Pharmaceutical Ltd. - October 31, 2025

An FDA inspection of Lonza Guangzhou Pharmaceutical Ltd., an API manufacturer in Nansha District, China, revealed significant deficiencies in its quality unit operations. The firm released API batches to the U.S. market without ensuring safety levels of impurities and conducted inadequate complaint investigations for foreign matter. Additionally, the quality system for approving contract laboratories performing critical impurity testing was found to be deficient.