FDA 483 - Takeda Ireland Ltd - February 04, 2022

An FDA inspection of Takeda Ireland Ltd in Dublin, Ireland, revealed significant deficiencies in their quality control and manufacturing processes. Observations included inadequate investigations into discrepancies, failure to establish supplier reliability for API, and incomplete laboratory records lacking audit trail reviews. Additionally, the firm's stability program, quality unit responsibilities, and employee training were found to be deficient, indicating a need for comprehensive improvements in their quality management system.