FDA 483 - Takeda Pharmaceutical Company Limited - November 26, 2019

An FDA inspection of Takeda Pharmaceutical Company Limited in Hikari, Japan, a sterile drug manufacturer, revealed significant deficiencies across its quality system, production, laboratory controls, and facilities and equipment. The firm failed to ensure adequate quality unit oversight, proper aseptic processing validation, thorough investigations into product failures, and consistent equipment maintenance. These issues indicate a lack of adherence to written procedures and pose potential risks to drug product sterility and quality.