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

Source: https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/8afecc1c-3ccb-412d-b8a3-650f55ba2787

> 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: Office of Pharmaceutical Manufacturing Assessment
- Summary: An FDA inspection conducted at the Takasaki Plant of Kyowa Kirin Co., Ltd., a drug substance manufacturer in Japan, from August 24 to August 30, 2021, revealed significant observations concerning their manufacturing practices. The FDA 483 document highlighted several areas requiring immediate attention to ensure compliance with regulatory standards. Key issues included the absence of an adequately established cleaning and sanitization program, with disinfectant studies not supporting procedures for all manufacturing surfaces and disinfection SOPs lacking sufficient detail and documentation for contact times. Furthermore, the firm demonstrated inadequate procedural controls for electronic data acquisition and process control systems, showing unvalidated software, common user credentials, and insufficient review of electronic records and audit trails for critical equipment and lab systems. The inspection also found that Standard Operating Procedures were either not followed or were inadequate, particularly regarding sample collection, material handling (including unlabeled items), and the storage and tracking of Working Reference Standards. Concerns were raised about the effectiveness of cleaning procedures for product-contact equipment, as verification methods were not validated, and recovery studies lacked comprehensive representation of soils and surfaces. Critical clean utilities and manufacturing equipment were also found to be inadequately qualified and maintained, with issues such as insufficient sampling, unverified environmental control systems, and an observed leak from a tank. Kyowa Kirin Co., Ltd. is required to respond to these observations, detailing the corrective and preventive actions implemented to address these deficiencies and ensure adherence to cGMP regulations.

## Related Documents

- [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/1f9e13fc-f3bd-4e84-a15c-87d3e56e3b7c)

## Related Officers

- [Zhong Li](https://www.keypedia.com/people/zhong-li/18545b20-7fa5-4850-9dd4-cffb40c41f8d)
- [Jacek Cieslak](https://www.keypedia.com/people/jacek-cieslak/81b12add-49f1-4dfd-bcb1-60bc5b212b68)

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

Office: https://www.keypedia.com/offices/office-of-pharmaceutical-manufacturing-assessment/fe47b0bd-c1c6-4458-a8c9-15e4b073d3df