FDA 483 - WuXi Biologics Ireland Limited - December 16, 2025

WuXi Biologics Ireland Limited, a drug substance manufacturer in Dundalk, Ireland, was cited for deficiencies across its manufacturing and laboratory operations. Observations included high defect rates in manufacturing equipment, inadequate laboratory controls leading to high invalid assay rates, poor documentation practices, and inappropriate Out of Specification (OOS) investigation procedures. These issues indicate a need for improved quality system oversight and corrective actions.