Yangzhou Aurisco Pharmaceutical Co.,Ltd. – FDA 483, Jun 19, 2026

An FDA inspection of Yangzhou Aurisco Pharmaceutical Co., Ltd. in Yangzhou, China, an API manufacturer, revealed significant deficiencies in their quality control and manufacturing processes. The firm failed to adequately establish and follow procedures to assure drug substance identity, strength, quality, and purity, specifically regarding stability studies and testing. Furthermore, the inspection found a lack of adequate statistical methods for process validation and a failure to identify and document Critical Quality Attributes and Critical Process Parameters for API manufacturing.