# FDA 483 - Kyowa Kirin Co., Ltd. - Unknown Date

Source: https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/cdb3a990-02b4-443d-be78-b4e6a37494d1

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

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## Details

- Record Type: 483
- Company Name: Kyowa Kirin Co., Ltd.
- Product Type: drugs
- Office Name: Division of Advertising & Promotion 
- Summary: Kyowa Hakko Kirin Co's drug substance manufacturing facility in Takasaki-shi, Gunma, Japan, was cited for several deficiencies during an FDA inspection. Observations included inadequate testing of critical materials, insufficient facility cleaning documentation, inappropriate bioburden limits for validation studies, and an inadequate out-of-specification investigation procedure. These issues indicate concerns with quality control and manufacturing practices.

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## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)
- [Chen Sun](https://www.keypedia.com/people/chen-sun/f6a51adc-af97-4e40-aa07-eff034049750)

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

Office: https://www.keypedia.com/offices/division-of-advertising-promotion/adcc8282-aca9-4610-955c-e6553c7619b0