FDA 483 - Takeda Pharmaceuticals USA, Inc.

An FDA inspection of Takeda Pharmaceuticals USA, Inc. in Deerfield, IL, identified a significant issue regarding the conduct of clinical investigations. The firm failed to ensure that studies were conducted in accordance with their general investigational plans and protocols. Specifically, problems were noted with subject randomization and stratification in two clinical studies, leading to a substantial number of mis-stratified or ineligible subjects.