FDA 483 - Gaoyou Qinyou Biological Technology Co., Ltd. - October 18, 2021

During an inspection, Gaoyou Qinyou Biological Technology Co., Ltd., an API manufacturer in Yangzhou, China, was cited for deficiencies in equipment cleaning and maintenance. Inspectors observed a production tank labeled as cleaned that contained rust-like spots and lubricant spills on product contact areas, indicating a failure to follow established cleaning procedures. These findings raise concerns about the firm's adherence to quality standards for its crude heparin sodium products.