# FDA 483 - Daiichi Sankyo Chemical Pharma Co., Ltd. - July 01, 2021

Source: https://www.globalkeysolutions.net/records/483/daiichi-sankyo-chemical-pharma-co-ltd/7ce9fe39-58c7-4948-867e-0ea069c003d8

> FDA 483 for Daiichi Sankyo Chemical Pharma Co., Ltd. on July 01, 2021. 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: 2021-07-01
- Product Type: drugs
- Office Name: International Compliance Team
- Summary: This 483 report for Daiichi Sankyo Chemical Pharma Co., Ltd. in Gunma, Japan, details significant deficiencies in manufacturing process control, quality unit separation, deviation and CAPA management, facility cleaning procedures, and pest control. The observations indicate a lack of adherence to established procedures, ineffective corrective actions, and potential risks to product quality and facility integrity. The inspection identified repeated issues, highlighting systemic problems in quality oversight and operational compliance.

## Related Officers

- [company_representative](https://www.globalkeysolutions.net/people/jay-liu/ce027926-de45-4c6b-af95-4db118f17861)
- [ Investigator, Consumer Safety Officer](https://www.globalkeysolutions.net/people/thuy-t-nguyen/1cfb5467-f0b7-49b8-85c1-00373692e35e)

Company: https://www.globalkeysolutions.net/companies/daiichi-sankyo-chemical-pharma-co-ltd/a064e117-8b08-4d66-a00a-a3809aabf9b0

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321