# FDA 483 - Takeda Ireland Ltd - February 04, 2022

Source: https://www.keypedia.com/records/483/takeda-ireland-ltd/c1dfc5bf-9d34-4f82-8b16-872e6bdd498f

> FDA 483 for Takeda Ireland Ltd on February 04, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Ireland Ltd
- Inspection Date: 2022-02-04
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: 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.

## Related Officers

- [Compliance Officer](https://www.keypedia.com/people/yasamin-ameri/73021772-c960-4c65-aa30-cb490866ee58)

Company: https://www.keypedia.com/companies/takeda-ireland-ltd/88620821-e6b8-454b-ac4f-4729be466d67

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1