FDA 483 - Wuxi Biologics Co Ltd - April 02, 2021

WuXi Biologics Co. Ltd. in Mashan, Wuxi, Jiangsu, China, a drug substance and drug product manufacturer, was cited with six observations during an FDA inspection. The observations highlight significant deficiencies in computer system controls, quality unit oversight of documents, inadequate preventative maintenance schedules, and insufficient raw material specifications. Additionally, the firm failed to consistently initiate effectiveness checks for CAPAs and thoroughly investigate product complaints and discrepancies.