Beigene (Suzhou) Co., Ltd. – FDA 483, Jun 16, 2023

An FDA inspection of BeiGene (Suzhou) Co., Ltd, a drug manufacturer, revealed significant deficiencies in laboratory controls, analytical method validation, data integrity practices, and equipment qualification. The firm failed to ensure scientifically sound test procedures, adequately validate an HPLC method, maintain data integrity for testing systems, and properly qualify a particle size meter. These issues indicate a lack of assurance in the quality and purity of their drug products.