# FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - January 25, 2019

Source: https://www.keypedia.com/records/483/daiichi-sankyo-chemical-pharma-co-ltd/aeedd5d2-72f2-4896-a258-2bbd6991fadf

> FDA 483 for Daiichi Sankyo Chemical Pharma Co., Ltd. on January 25, 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: 2019-01-25
- Product Type: drugs
- Office Name: Office of Partnerships
- Summary: An FDA Form 483 was issued to Daiichi Sankyo Chemical Pharma Co., Ltd. in Odawara, Japan, an API manufacturer. The inspection revealed deficiencies related to the retention of documentation for primary reference standards, the suitability determination of secondary reference standards, stability testing practices for drug substance intermediates, and the thoroughness of investigations into unexplained discrepancies.

## Related Officers

- [Pharmaceutical Program Expert](https://www.keypedia.com/people/zachary-l-stamm/b729fab9-4d31-4c70-b5b3-e8b6207769c6)

Company: https://www.keypedia.com/companies/daiichi-sankyo-chemical-pharma-co-ltd/83cd6ae3-96fe-46bb-85a7-2aee947e573b

Office: https://www.keypedia.com/offices/office-of-partnerships/83acc701-fc5a-4876-bb34-7499e31541d3