# 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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## Related Officers

- [Biologist](https://www.keypedia.com/people/jacek-cieslak/59683a5f-277f-41b8-be10-0dc82b7596f3)
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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