# FDA 483 - Takeda Pharmaceuticals USA, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/takeda-pharmaceuticals-usa-inc/da485ef1-26ca-4a32-9311-d2bcb54158ac

> FDA 483 for Takeda Pharmaceuticals USA, Inc. on Unknown Date. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceuticals USA, Inc.
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Takeda Pharmaceuticals USA, Inc. in Deerfield, IL, identified a significant issue regarding the conduct of clinical investigations. The firm failed to ensure that studies were conducted in accordance with their general investigational plans and protocols. Specifically, problems were noted with subject randomization and stratification in two clinical studies, leading to a substantial number of mis-stratified or ineligible subjects.

## Related Documents

- [483 - 2016-09-09](https://www.keypedia.com/records/483/takeda-pharmaceuticals-usa-inc/5be6121b-721f-41ef-baf1-a0f0a4712881)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/jennifer-c-adams/85608566-bd13-41d8-b86e-cc9111c7dfe5)

Company: https://www.keypedia.com/companies/takeda-pharmaceuticals-usa-inc/678d8802-0216-41d5-bdd6-38999c144876

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