# FDA 483 - Takeda Pharmaceutical Company Limited - November 26, 2025

Source: https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/e314f461-7a2b-42e9-9181-710be64dee9c

> FDA 483 for Takeda Pharmaceutical Company Limited on November 26, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2025-11-26
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: BAXALTA US INC. in Round Lake, IL, was inspected regarding its Flexbumin manufacturing operations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into false positive contamination recoveries and recurring particulate matter. The firm also lacked scientifically sound laboratory controls for cross-contamination and failed to follow written procedures for production, process controls, and equipment cleaning.

## Related Documents

- [483 - 2022-09-15](https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/4e49acd1-ce68-49ee-bfe4-8266281bdf7c)

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)
- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)

Company: https://www.keypedia.com/companies/takeda-pharmaceutical-company-limited/4611dabc-52f7-4b4a-96bf-4196e34a7c2b

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669