FDA 483 - WestChina-Frontier PharmaTech Co, Ltd - July 25, 2025

An FDA inspection of WestChina-Frontier PharmaTech Co., Ltd. in Chengdu, China, revealed significant Good Laboratory Practice (GLP) deficiencies. The firm failed to ensure timely archiving of study materials and related correspondence. Additionally, the quality assurance unit did not properly document deviations from approved protocols.