# FDA 483 - Kyowa Kirin Co., Ltd. - December 03, 2018

Source: https://www.keypedia.com/records/483/kyowa-kirin-co-ltd/0a42ecc7-80ff-4c7a-9d3e-067fae1aa57d

> FDA 483 for Kyowa Kirin Co., Ltd. on December 03, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kyowa Kirin Co., Ltd.
- Inspection Date: 2018-12-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Kyowa Hakko Kirin Co., a drug manufacturer in Takasaki-shi, Japan, received a Form 483 for multiple deficiencies observed during an FDA inspection. The findings highlight significant issues across quality control, production, and laboratory systems, indicating a need for improved written procedures, environmental monitoring, and robust investigation processes. The firm's practices were found to be inadequate in ensuring product quality and preventing contamination.

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## Related Officers

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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/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1