# FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - November 08, 2019

Source: https://www.keypedia.com/records/483/daiichi-sankyo-chemical-pharma-co-ltd/0da57ba4-3f2c-4b5d-9103-cf032e02de4a

> FDA 483 for Daiichi Sankyo Chemical Pharma Co., Ltd. on November 08, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Daiichi Sankyo Chemical Pharma Co., Ltd.
- Inspection Date: 2019-11-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd.'s Onahama Plant, a drug substance manufacturer, revealed five observations. The findings primarily concerned deficiencies in quality unit approval of procedures, inadequate environmental monitoring, insufficient disinfectant efficacy studies, and scientifically unjustified equipment qualifications. These issues indicate a need for improved quality system controls and validation practices.

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## Related Officers

- [Jun Liu](https://www.keypedia.com/people/jun-liu/39e5d6f3-32fd-426f-880d-3d840a9faed2)
- [FDA Biologics Investigator](https://www.keypedia.com/people/viviana-matta/6fecf0ca-0edc-4538-a57e-72642f41b5c7)
- [Ralph M. Bernstein](https://www.keypedia.com/people/ralph-m-bernstein/72173dfb-24ae-42a1-af9e-1dc7da02ed87)

Company: https://www.keypedia.com/companies/daiichi-sankyo-chemical-pharma-co-ltd/846f1b3f-281e-4616-ae05-902bf9bcb28c

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