# FDA 483 - Yuki Gosei Kogyo Co., Ltd. - July 26, 2021

Source: https://www.globalkeysolutions.net/records/483/yuki-gosei-kogyo-co-ltd/8700b1bd-eea2-448e-a157-3769644beb34

> FDA 483 for Yuki Gosei Kogyo Co., Ltd. on July 26, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Yuki Gosei Kogyo Co., Ltd.
- Inspection Date: 2021-07-26
- Product Type: drugs
- Office Name: Center for Veterinary Medicine
- Summary: An FDA inspection of Yuki Gosei Kogyo Co., Ltd. in Iwaki, Fukushima, Japan, a drug substance manufacturer, revealed significant deficiencies in its quality unit and laboratory control systems. Observations included a failure to implement timely corrective actions for recurring data integrity issues with Distributed Control Systems, inadequate evaluation of alarm events, and a lack of effective CAPA for repeated HPLC system suitability failures. Additionally, the firm failed to perform working sample stability studies and lacked scientific justification for discarding original samples.

## Related Documents

- [483 - 2017-11-17](https://www.globalkeysolutions.net/records/483/yuki-gosei-kogyo-co-ltd/a9b112fb-f569-47d0-b5a1-0aafaf4b8017)

## Related Officers

- [Quality System Specialist](https://www.globalkeysolutions.net/people/jose-e-melendez/75bd6083-14a4-4bd2-a0e5-9946d4dd37e1)

Company: https://www.globalkeysolutions.net/companies/yuki-gosei-kogyo-co-ltd/94411f09-2744-47ca-9250-20774e61824e

Office: https://www.globalkeysolutions.net/offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4