FDA EIR - Wuxi Biologics Co Ltd - April 08, 2019

An FDA Good Manufacturing Practice (GMP) inspection of Wuxi Biologics Co Ltd, located in Wuxi, China, occurred from April 8 to April 16, 2019. This inspection focused on the manufacturing of biological therapeutic drug substance and sterile liquid drug products, conducted under established CPGMs for Drug Manufacturing Inspections, Sterile Drug Process Inspections, and Biological Therapeutic Drug Products, referencing Q7 guidelines. The inspection identified several deficiencies, resulting in an FDA Form 483. Key violations included the company's failure to adhere to established Standard Operating Procedures (SOPs), inadequate implementation of Corrective and Preventive Actions (CAPAs) to address negative trend data, insufficient retention of required samples, and incomplete evaluation of analytical methods. These findings are consistent with some issues from a previous 2017 inspection. In response to the current findings, company management initiated corrective actions during the inspection and committed to providing a formal written response to the FDA. The inspection was classified as "Voluntary Action Indicated" (VAI) and routine surveillance, indicating that the firm is expected to voluntarily correct the observed deficiencies and provide a written explanation of how they will be addressed.