# FDA 483 - Kyowa Kirin Co., Ltd. - August 30, 2021

Source: https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/1f9e13fc-f3bd-4e84-a15c-87d3e56e3b7c

> FDA 483 for Kyowa Kirin Co., Ltd. on August 30, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Kirin Co., Ltd.
- Inspection Date: 2021-08-30
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Kyowa Kirin Co., Ltd.'s Takasaki Plant, a drug substance manufacturer, revealed significant deficiencies across its quality systems. Observations included inadequate cleaning and sanitization programs, unvalidated electronic data systems lacking proper controls, and a failure to follow or establish adequate standard operating procedures. Additionally, the firm lacked assurance in cleaning procedure effectiveness, critical utility qualification, equipment qualification, and facility maintenance.

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- [483 - 2018-12-03](https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/0a42ecc7-80ff-4c7a-9d3e-067fae1aa57d)
- [483 - Unknown Date](https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/cdb3a990-02b4-443d-be78-b4e6a37494d1)
- [483 - 2021-08-30](https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/8afecc1c-3ccb-412d-b8a3-650f55ba2787)

## Related Officers

- [Jacek Cieslak, Ph.D., Chemist](https://www.keypedia.com/people/jacek-cieslak-phd-chemist/52653877-415a-4dfd-b5e1-820bab165d96)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)

Company: https://www.keypedia.com/companies/kyowa-kirin-co-ltd/9d964de3-aa1c-4983-801e-474266e4b6d2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd