# FDA 483 - Takeda Pharmaceutical Company Limited - July 19, 2021

Source: https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/d7328c43-e92f-449d-bccf-293394b50bdc

> FDA 483 for Takeda Pharmaceutical Company Limited on July 19, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2021-07-19
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Takeda Pharmaceutical Company Limited in Yamaguchi, Japan, a sterile drug product manufacturer, revealed significant deficiencies. The firm failed to ensure process simulation studies were representative of commercial operations and had inadequate environmental monitoring in aseptic areas. Additionally, the quality control unit's investigation oversight was found lacking, and critical controls for incoming materials were not established, leading to foreign particle contamination in drug products.

## Related Documents

- [483 - 2023-11-06](https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/9830bf69-579a-4bc0-bf7c-8ad2b78a6e53)
- [483 - 2019-11-26](https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/dc0ab72d-608b-4770-b885-4d26b8d7b7cf)
- [483 - 2019-11-26](https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/58fc4bcb-d16e-4868-88eb-9a01737e1cc2)
- [483 - 2023-11-01](https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/1896dda4-c7e8-4da9-b91a-daba1da128bc)
- [483 - 2021-07-19](https://www.globalkeysolutions.net/records/483/takeda-pharmaceutical-company-limited/116551bc-ee0b-45cf-ba4f-c6c4be7fe3d5)

## Related Officers

- [Vincent Thomas](https://www.globalkeysolutions.net/people/vincent-thomas/0925480c-5d8c-411f-86ee-5e4b924f8c12)
- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/takeda-pharmaceutical-company-limited/0f6bd1ca-94a2-41f0-a8dd-1af20069e6cf

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