FDA 483 - HEC Pharm Co., Ltd. - November 21, 2025

An FDA inspection of HKC Pharm Co. Ltd. in Yidu, Hubei, an API manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequately validated analytical methods for impurities, unqualified laboratory instruments and software impacting data integrity, and unvalidated culture media for microbial monitoring. Additionally, manufacturing equipment was not properly maintained, and the manufacturing computer system was inadequately qualified, leading to product loss.