FDA 483 - Guangzhou Hanpu Pharmaceutical Co. Ltd. - December 13, 2024

An FDA inspection of Guangzhou Hanpu Pharmaceutical Co.,Ltd, an API manufacturer in Guangzhou, China, revealed significant quality system deficiencies. Observations included failures in the quality unit's responsibilities regarding recovered solvent testing, equipment maintenance, cleaning validation, and stability data. Additionally, the firm's computerized systems lacked adequate data integrity controls, and batch production records had an insufficient numbering system.