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

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.