# FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - December 22, 2023

Source: https://www.keypedia.com/records/483/daiichi-sankyo-chemical-pharma-co-ltd/db84195a-9672-4125-97a9-d2d9e88a89b4

> FDA 483 for Daiichi Sankyo Chemical Pharma Co., Ltd. on December 22, 2023. 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: 2023-12-22
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Daiichi Sankyo Chemical Pharma Co., Ltd. in Iwaki, Fukushima, Japan, revealed significant deficiencies in quality control and production processes. The firm failed to thoroughly investigate unexplained discrepancies, out-of-specification results, and foreign matter, and lacked adequate production controls to prevent residue build-up in equipment during API manufacturing campaigns. These issues indicate a lack of robust quality systems to ensure drug product quality.

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## Related Officers

- [Investigator](https://www.keypedia.com/people/jolanna-a-norton/5501fea4-4bfd-434c-b2aa-fcf94444f684)

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

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