FDA 483 - Takeda Pharmaceutical Company Limited - November 26, 2025

BAXALTA US INC. in Round Lake, IL, was inspected regarding its Flexbumin manufacturing operations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into false positive contamination recoveries and recurring particulate matter. The firm also lacked scientifically sound laboratory controls for cross-contamination and failed to follow written procedures for production, process controls, and equipment cleaning.