FDA 483 - Lonza Guangzhou Pharmaceutical Ltd. - October 27, 2026

During an inspection conducted from October 27-31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Lonza Guangzhou Pharmaceutical Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in China. The inspection revealed significant deviations from Current Good Manufacturing Practices (CGMP).

Key observations highlighted critical failures within the firm"s quality unit. Specifically, the company released numerous API batches to the U.S. market without sufficient assurance that impurity levels were within safe limits. The FDA also noted inadequate investigations into product quality complaints. For instance, reports of black particles and foreign matter in API batches lacked thorough root cause analysis, evaluation of reserve samples, and the establishment of appropriate corrective and preventive actions before the affected products were distributed. Furthermore, the firm"s quality system for approving and overseeing contract laboratories performing critical impurity testing was deemed deficient, raising concerns about the reliability of such testing.

These observations indicate a need for Lonza Guangzhou Pharmaceutical Ltd. to implement robust corrective and preventive actions to ensure the quality and safety of APIs supplied to the U.S. market, aligning with regulatory expectations for pharmaceutical manufacturing.