FDA 483 - Jiangsu Tianhe Pharmaceutical Co. - February 28, 2025

Jiangsu Tianhe Pharmaceutical Co. in Yangzhou, China, received a Form FDA 483 with five observations during an inspection from February 24-28, 2025. The inspection revealed significant deficiencies in manufacturing process validation, equipment qualification, alarm management, stability sampling plans, analytical method validation, and overall quality unit oversight, including data integrity issues. Several observations were repeats from a previous inspection, indicating persistent compliance problems.