# FDA 483 - Sumika Chemical Analysis Service, Ltd. - November 13, 2019

Source: https://www.globalkeysolutions.net/records/483/sumika-chemical-analysis-service-ltd/e076b85e-9fa6-41c7-ac5b-55fe37a759c0

> FDA 483 for Sumika Chemical Analysis Service, Ltd. on November 13, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sumika Chemical Analysis Service, Ltd.
- Inspection Date: 2019-11-13
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Sumika Chemical Analysis Service, Ltd., a contract testing laboratory in Oita, Japan, revealed a critical data integrity issue. The firm failed to ensure that backup data from stand-alone analytical instruments was secure from alteration, erasure, or loss. This deficiency impacts the reliability of testing data for various APIs and drug products supplied to the US market.

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/sumika-chemical-analysis-service-ltd/075ab6c9-b05d-47d0-8d9a-0aa4807153a6

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