FDA 483 - Takeda Manufacturing Singapore Pte. Ltd. - November 10, 2022

An FDA inspection of Takeda Singapore Pte. Ltd., a licensed biological manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately investigate unexplained discrepancies and negative trends, often lacking identified root causes, immediate corrections, or proper CAPA initiation and justification. Additionally, the quality control unit's responsibilities and procedures were not fully followed, with inadequate training in Good Documentation Practices and data integrity leading to multiple instances of missing or inconsistent electronic data.