# FDA 483 - Yuki Gosei Kogyo Co., Ltd. - February 02, 2026

Source: https://www.keypedia.com/records/483/yuki-gosei-kogyo-co-ltd/c06cb942-22d8-4e1e-b692-c825c0e97f0f

> FDA 483 for Yuki Gosei Kogyo Co., Ltd. on February 02, 2026. 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: 2026-02-02
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: Yuki Gosei Kogyo, Co., Ltd. in Iwaki-shi, Japan, an API manufacturer, received a Form 483 citing significant deficiencies in quality systems. Observations included inadequate and untimely complaint investigations, a lack of procedures for testing objectionable microorganisms in water used for API production, and deficient supplier qualification practices. These issues indicate a moderate level of severity, impacting product quality and patient safety.

## Related Documents

- [483 - 2017-11-17](https://www.keypedia.com/records/483/yuki-gosei-kogyo-co-ltd/a9b112fb-f569-47d0-b5a1-0aafaf4b8017)
- [483 - 2021-07-26](https://www.keypedia.com/records/483/yuki-gosei-kogyo-co-ltd/8700b1bd-eea2-448e-a157-3769644beb34)

## Related Officers

- [Consumer Safety Officer - Dedicated Foreign Drug Cadre](https://www.keypedia.com/people/tamil-arasu/94efc491-7d9f-4221-a1ee-69a925acb1c3)

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

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3