FDA 483 - Eurofins BioPharma Product Testing ENCO Inc. - September 25, 2025

An FDA inspection of Eurofins BioPharma Product Testing ENCO, LLC in Jacksonville, FL, revealed a significant deficiency in the firm's record-keeping practices. The firm failed to include written records of major equipment use in individual equipment logs, and identified gaps in retrieving these logs through their new eLIMS system. This issue impacts analytical instruments such as HPLC, GC, IC systems, and a Viscometer, indicating a potential data integrity concern.