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

An FDA inspection of Takeda Pharmaceutical Company Limited in Yamaguchi, Japan, revealed critical deficiencies in sterile drug product manufacturing and quality control. The firm failed to adequately simulate critical interventions during media fills and exhibited inadequate environmental monitoring in aseptic processing areas. Additionally, the quality control unit did not fully adhere to its procedures, and the company lacked proper controls for incoming components, resulting in foreign particle contamination.