# FDA 483 - Astellas Pharma Inc. - October 27, 2023

Source: https://www.keypedia.com/records/483/astellas-pharma-inc/b94c8cff-f872-4329-959e-7bc41db048a4

> FDA 483 for Astellas Pharma Inc. on October 27, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Astellas Pharma Inc.
- Inspection Date: 2023-10-27
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Astellas Pharma Inc. in Yaizu, Shizuoka, Japan, a drug manufacturer, revealed significant deficiencies in their complaint handling system. Specifically, market complaint records lacked scientifically sound justification for root causes, and investigations failed to include essential reviews such as batch, analytical data, and retain sample trending.

## Related Documents

- [483 - 2023-10-27](https://www.keypedia.com/records/483/astellas-pharma-inc/5b413ad6-1e93-43ac-b833-243a21e7ec66)

## Related Officers

- [Michele Gottshall](https://www.keypedia.com/people/michele-gottshall/f12dcaf7-8958-4591-88bb-f9746796b934)

Company: https://www.keypedia.com/companies/astellas-pharma-inc/b0bdaca5-537e-4e43-9609-7ae4702f2f86

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