# FDA 483 - Nippon Shinyaku Co., Ltd. - November 09, 2019

Source: https://www.keypedia.com/records/483/nippon-shinyaku-co-ltd/ecf8042b-56cf-4080-8948-6079e1f725e1

> FDA 483 for Nippon Shinyaku Co., Ltd. on November 09, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Nippon Shinyaku Co., Ltd.
- Inspection Date: 2019-11-09
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Nippon Shinyaku Co., Ltd. in Kyoto, Japan, revealed significant deficiencies in laboratory controls and data integrity practices. Observations included incomplete laboratory records, lack of audit trail review, inadequate computer system controls, and uncontrolled laboratory worksheets. These issues raise concerns about the reliability of data used for clinical studies and regulatory submissions.

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.keypedia.com/companies/nippon-shinyaku-co-ltd/a7a22b36-4752-4fe4-a013-c7480b538c32

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1