Takeda Pharmaceuticals U.S.A., Inc. – FDA 483, Mar 18, 2020

Takeda Pharmaceuticals U.S.A., Inc. in Brooklyn Park, MN, a drug substance manufacturer, was issued a Form 483 with three observations. The inspection revealed inadequate cleaning validation for manufacturing equipment, insufficient quality oversight for outsourced qualification studies, and deficiencies in Standard Operating Procedures. These issues indicate potential risks to product quality and control.