FDA 483 - Takeda Manufacturing Singapore Pte. Ltd. - August 15, 2025

Takeda Manufacturing Singapore Pte. Ltd., a licensed biological drug manufacturer, received a Form 483 for significant deficiencies observed during an FDA inspection. The firm was cited for inadequate investigations into manufacturing deviations, failures in validating manufacturing processes and cleaning procedures, and critical shortcomings within the quality unit, including a lack of written procedures and insufficient training oversight. These issues resulted in the release of impacted drug substance batches to the U.S. market and identified contamination risks.