FDA 483 - Mitsubishi Tanabe Pharma Factory Ltd. - January 15, 2026

An FDA inspection of Mitsubishi Tanabe Pharma Factory Ltd. in Yamaguchi, Japan, an API manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate cleaning validation for shared equipment, insufficient laboratory controls for related substance testing, and poor procedures for material storage. Additionally, the firm failed to thoroughly investigate unexplained discrepancies and lacked proper controls for electronic data and audit trails.