# FDA 483 - Takeda Pharmaceuticals USA, Inc. - September 09, 2016

Source: https://www.keypedia.com/records/483/takeda-pharmaceuticals-usa-inc/5be6121b-721f-41ef-baf1-a0f0a4712881

> FDA 483 for Takeda Pharmaceuticals USA, Inc. on September 09, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Takeda Pharmaceuticals USA, Inc.
- Inspection Date: 2016-09-09
- Product Type: drugs
- Office Name: Chicago District Office
- Summary: An FDA inspection of Takeda Development Center Americas, Inc. revealed significant deficiencies in their pharmacovigilance system, primarily concerning the timely reporting of adverse drug experiences. The firm failed to report serious and unexpected adverse drug events and their follow-up information within the required 15 calendar days, with delays extending up to 2.5 years. Additionally, the inspection found issues with the review of adverse drug experience information, the reliability of electronic records, and the effectiveness of corrective and preventative actions and data exchange systems.

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/takeda-pharmaceuticals-usa-inc/da485ef1-26ca-4a32-9311-d2bcb54158ac)

## Related Officers

- [Bryan L. Mcguckin](https://www.keypedia.com/people/bryan-l-mcguckin/33eaa16d-a642-4945-81f3-5d9ac180c2db)

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