Changzhou Yabang-QH Pharmachem Co., Ltd. – FDA 483, Jul 24, 2026

Changzhou Yabang-QH Pharmachem Co. Ltd., an API manufacturer in Changzhou, China, received three observations during an FDA inspection. The findings include concerns regarding data integrity in their chromatography data system, inadequate evaluation of chemical migration and spillage in their warehouse, and a lack of assessment for potential microbiological or chemical contaminant buildup during consecutive batch manufacturing campaigns. These issues indicate potential deficiencies in quality control and manufacturing practices.