FDA 483 - Takeda Pharmaceutical Company Limited - September 18, 2015

An FDA inspection of Takeda Pharmaceutical Company Limited's Osaka Plant in Japan revealed two significant observations related to human drug manufacturing. The firm was cited for incomplete laboratory records regarding process simulations, specifically the justification for using a particular substance, and for inadequate viewing capabilities of sterile product manufacturing processes, hindering proper inspection and monitoring of aseptic techniques. These issues raise concerns about the integrity of their aseptic processing and quality control unit.