# FDA 483 - Fuji Yakuhin Co., Ltd. - November 25, 2022

Source: https://www.keypedia.com/records/483/fuji-yakuhin-co-ltd/5b637290-938f-4705-abff-d1e01c51ea03

> FDA 483 for Fuji Yakuhin Co., Ltd. on November 25, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fuji Yakuhin Co., Ltd.
- Inspection Date: 2022-11-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a sterile drug manufacturer, was inspected by the FDA. The inspection revealed significant deficiencies in aseptic manufacturing practices, including improper operator techniques and inadequate airflow studies. Additionally, the firm failed to properly qualify equipment and retain samples of active drug substances.

## Related Documents

- [483 - 2019-11-26](https://www.keypedia.com/records/483/fuji-yakuhin-co-ltd/15f40bdb-099d-4908-9b4f-1e6bfc4e13f9)
- [483 - 2022-11-25](https://www.keypedia.com/records/483/fuji-yakuhin-co-ltd/4e14499d-729d-400e-9493-5514fda018e0)

## Related Officers

- [Robert J. Martin](https://www.keypedia.com/people/robert-j-martin/8bd5c75a-ec53-4ae5-9739-a39489686cae)

Company: https://www.keypedia.com/companies/fuji-yakuhin-co-ltd/88530942-e172-4a65-8c32-4495fdaa6b61

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