# FDA 483 - Takeda Pharmaceutical Company Limited - September 15, 2022

Source: https://www.keypedia.com/records/483/takeda-pharmaceutical-company-limited/4e49acd1-ce68-49ee-bfe4-8266281bdf7c

> FDA 483 for Takeda Pharmaceutical Company Limited on September 15, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceutical Company Limited
- Inspection Date: 2022-09-15
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: An FDA inspection of Takeda Pharmaceutical Company Limited in Round Lake, IL, revealed three significant observations. The firm failed to microbiologically test incoming bulk albumin for objectionable organisms, did not thoroughly review unexplained discrepancies and batch failures related to endotoxin, and exhibited deficiencies in validating supplier test results and auditing contract laboratories for critical utilities. These issues highlight concerns in quality control and supplier oversight for a licensed biological drug manufacturer.

## Related Officers

- [CO CDER OMQ](https://www.keypedia.com/people/claire-minden/f48982ad-244e-41a8-932a-5d7a2392f0e3)

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