FDA 483 - Takeda Pharmaceutical Company Limited - July 19, 2021

An FDA inspection of Takeda Pharmaceutical Company Limited in Yamaguchi, Japan, a sterile drug product manufacturer, revealed significant deficiencies. The firm failed to ensure process simulation studies were representative of commercial operations and had inadequate environmental monitoring in aseptic areas. Additionally, the quality control unit's investigation oversight was found lacking, and critical controls for incoming materials were not established, leading to foreign particle contamination in drug products.