Wuxi Biologics Co Ltd – FDA 483, May 9, 2023

Wuxi Biologics Co. Ltd. in Wuxi, Jiangsu, China, a drug substance and sterile drug product manufacturer, was cited for significant deficiencies across its quality unit oversight, visual inspection program, aseptic processing area cleaning, in-process parameter setup, and validation studies. The inspection revealed issues with batch release, sterility testing, contamination control, particle inspection, hold time validations, and cleaning documentation. These observations indicate a systemic lack of control over critical manufacturing processes and quality assurance.