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

During an FDA inspection from October 27-31, 2025, Lonza Guangzhou Pharmaceutical Ltd., an API manufacturer in China, received a Form 483 citing significant deficiencies in its quality management systems and adherence to Good Manufacturing Practices. The primary violations centered on the company's quality unit not fully meeting its responsibilities. Since 2023, the firm released numerous active pharmaceutical ingredient (API) batches containing unacceptable impurity levels or without adequate assurance of safety regarding impurities. Additionally, the inspection found a failure to thoroughly investigate unexplained discrepancies and batch failures. Complaint investigations were inadequate, specifically regarding black particles and foreign matters observed during drug product manufacturing. These investigations often failed to evaluate reserve samples, identify root causes, or implement effective corrective actions, even for batches released to the U.S. market. Lastly, the FDA identified a deficient quality system for approving contract laboratories. The quality unit failed to ensure that external laboratories performing critical impurity testing possessed the necessary capabilities, equipment, and expertise for accurate and reliable analyses. Lonza Guangzhou Pharmaceutical Ltd. is required to submit a detailed response to the FDA, outlining the corrective and preventive actions it will take to address these serious observations and ensure compliance with regulatory standards.