FDA 483 - Takeda Pharmaceutical Company Limited - November 06, 2023

During an FDA inspection conducted from October 25 to November 6, 2023, Takeda Pharmaceutical Company Limited's Hikari Plant in Japan received a Form FDA 483, detailing significant observations related to manufacturing practices for human drugs. The company was cited for failing to initiate comprehensive investigations into a negative trend of critical quality complaints concerning a specific drug/device product, and subsequently not implementing corrective and preventive actions. Additionally, the inspection revealed a failure to thoroughly review unexplained discrepancies and batch failures, including not conducting further evaluations when visual inspection action limits were reached and issues with defect classification. Deficiencies were also noted in the environmental monitoring system within aseptic processing areas, specifically concerning the placement of a non-viable particle counter. Lastly, Takeda was cited for not appropriately testing drug product batches for objectionable microorganisms, specifically regarding incomplete endotoxin testing procedures where required pH measurements were not performed. These observations indicate areas where the company's quality systems need improvement to ensure compliance with pharmaceutical manufacturing standards. Takeda is expected to address these findings with appropriate corrective actions to demonstrate compliance.