# FDA 483 - Sumitomo Chemical Co., Ltd. - September 06, 2019

Source: https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/16a1e111-f5ee-4741-889d-4fed4a9f7437

> FDA 483 for Sumitomo Chemical Co., Ltd. on September 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Chemical Co., Ltd.
- Inspection Date: 2019-09-06
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sumitomo Chemical Co., Ltd., an API manufacturer in Anpachi-Gun, Gifu, Japan, revealed significant deficiencies in data integrity, quality unit responsibilities, and certificate of analysis practices. The firm failed to conduct meaningful audit trail reviews for HPLC instruments, improperly delegated critical quality assurance duties, and issued Certificates of Analysis lacking essential information. These issues indicate a lack of adequate controls over manufacturing and quality processes.

## Related Documents

- [483 - 2016-09-20](https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/f014e97b-7130-4bc3-9a39-bd4194367cbf)
- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/a472768a-0694-48ca-9d2d-564aeeef4a53)

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)

Company: https://www.globalkeysolutions.net/companies/sumitomo-chemical-co-ltd/3ce10d51-6999-467f-ac0e-cb6696a98aa5

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