FDA 483 - Wuxi Biologics Co Ltd - May 09, 2023

The FDA Form 483 inspection revealed multiple deficiencies in the facility's operations.

**Quality Unit Oversight:** * Drug substance (DS) batches were partially released and manufactured into drug product (DP) before full Quality Unit release, including complete testing and document review. * Sterility test failures for DP PPQ Batches in September 2022 were invalidated without an unequivocal root cause, with retesting performed. The investigation attributed the likely cause to deficient sterilization of vendor-supplied sterility test media containers. * Written procedures do not address the disposition of process intermediates manufactured from production culture confirmed to be contaminated based on bioburden data.

**Manufacturing and Quality Control:** * The visual inspection program for DP vials is deficient; AQL acceptance criteria allow for visible particles (light, black, fibers) in released DP batches. * Cleaning and disinfection of aseptic processing areas are inadequate, as non-product contact surfaces within the RABS are not always disinfected with a sporicidal agent before each DP batch. * Process intermediate physicochemical stability validation studies are deficient. Hold time studies compared results from the start of storage of one step to the start of a subsequent purification/chromatography step, preventing proper assessment of hold time impact. * The pH value of the manufacturing process is not measured at the end of a specific step to ensure it remains within the target range. * Manual cleaning processes and testing results for DP