FDA 483 - Takeda Ireland Ltd - February 04, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · c1dfc5bf-9d34-4f82-8b16-872e6bdd498f