# FDA 483 - Eurofins Analytical Science Laboratories, Inc - January 31, 2024

Source: https://www.keypedia.com/records/483/eurofins-analytical-science-laboratories-inc/0fbcdcf5-07f4-43dc-a7b9-351de9456047

> FDA 483 for Eurofins Analytical Science Laboratories, Inc on January 31, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Eurofins Analytical Science Laboratories, Inc
- Inspection Date: 2024-01-31
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of Eurofins Analytical Science Laboratories, Inc, a contract testing laboratory in Kyoto, Japan, revealed significant deficiencies in their quality control unit. The firm failed to establish and follow adequate written procedures for electronic data review, facility access controls, and laboratory instrument conditioning. These issues indicate a lack of robust controls over data integrity and sample security.

## Related Officers

- [Teresa I. Navas](https://www.keypedia.com/people/teresa-i-navas/43f747c0-18c2-4630-bab9-936204aa93aa)

Company: https://www.keypedia.com/companies/eurofins-analytical-science-laboratories-inc/411617f9-5819-4526-91da-7a15192aac2c

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