FDA 483 - Eurofins PROXY Laboratories B.V. - September 19, 2025

Eurofins PROXY Laboratories B.V., a contract testing organization in Leiden, Netherlands, was inspected and cited for significant deficiencies across its quality control unit, laboratory operations, and procedural controls. Observations included untimely closure of deviations, inadequate investigation of out-of-specification results, and deficient written procedures for handling non-conformances. Additionally, the firm's cleanrooms used for sterility testing had an inadequate air pressure monitoring system, indicating a lack of robust quality systems and controls.