# FDA 483 - Fuji Yakuhin Co., Ltd. - November 26, 2019

Source: https://www.keypedia.com/records/483/fuji-yakuhin-co-ltd/15f40bdb-099d-4908-9b4f-1e6bfc4e13f9

> FDA 483 for Fuji Yakuhin Co., Ltd. on November 26, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fuji Yakuhin Co., Ltd.
- Inspection Date: 2019-11-26
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Fuji Yakuhin Co., Ltd. in Toyama-shi, Japan, a manufacturer of sterile drug products, revealed significant deficiencies. Observations included inadequate aseptic process validation, insufficient disinfectant efficacy studies, and critical issues with electronic record integrity and retention. Additionally, the firm failed to adequately qualify suppliers for container and closure components.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/darren-s-brown/389a4d1f-7f34-42cd-bdc8-5bebd41aff56)

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