# FDA 483 - Sumitomo Chemical Co., Ltd. - December 08, 2017

Source: https://www.globalkeysolutions.net/records/483/sumitomo-chemical-co-ltd/6e72c2a1-e334-4b8d-ba61-bc8cad9a1220

> FDA 483 for Sumitomo Chemical Co., Ltd. on December 08, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumitomo Chemical Co., Ltd.
- Inspection Date: 2017-12-08
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Sumitomo Chemical Co., Ltd. in Anpachi-Gun, Gifu Prefecture, Japan, was cited for significant deficiencies in laboratory controls, analytical method validation, and equipment cleaning during an FDA inspection. The firm failed to apply scientific rationale in testing, properly investigate out-of-specification results, ensure adequate employee training, and maintain equipment free of contaminants. Additionally, issues with computerized system traceability were noted.

## Related Officers

- [Pharmacy Compounding National Expert, Drug Specialist, Drug Specialist, Foreign Cadre](https://www.globalkeysolutions.net/people/jessica-l-pressley/2c190e50-81bd-4015-95f0-7177beb363bd)
- [Investigator](https://www.globalkeysolutions.net/people/marcellinus-d-dordunoo/a0e35c24-0cf5-4b11-95ba-1693fa3ecb3a)

Company: https://www.globalkeysolutions.net/companies/sumitomo-chemical-co-ltd/e29ee21c-1d89-4b68-b9b0-0a9105fdbb45

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd