# FDA 483 - Sumitomo Chemical Co., Ltd. - September 20, 2016

Source: https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/f014e97b-7130-4bc3-9a39-bd4194367cbf

> FDA 483 for Sumitomo Chemical Co., Ltd. on September 20, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Chemical Co., Ltd.
- Inspection Date: 2016-09-20
- Product Type: drugs
- Office Name: FDA District Office — Silver Springs, Maryland
- Summary: An FDA inspection of Sumitomo Chemical Co., Ltd. in Anpachi-cho, Gifu, Japan, an API manufacturer, revealed significant deficiencies in laboratory controls and document management. The firm failed to conduct proper investigations into unexplained laboratory discrepancies and did not retain raw data calculations. Additionally, the Quality unit exhibited inadequate control over the issuance of master production records.

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## Related Officers

- [Lindsey M. Schwinghamm](https://www.globalkeysolutions.net/people/lindsey-m-schwinghamm/260aeb66-1646-4365-a749-3bd21f36cd40)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-silver-springs-maryland/079bb75c-3759-4baa-baed-4159edd64552