FDA 483 - Eurofins Donor & Product Testing, Inc. Atlanta - November 05, 2024

Eurofins Donor & Product Testing, Inc. in Marietta, GA, was cited with two observations during an FDA inspection from October 29 to November 5, 2024. The firm failed to follow proper equipment calibration procedures, using incorrect specifications and incorrectly marking results as passing. Additionally, corrective actions for core Current Good Tissue Practice (CGTP) requirements were found to be inadequate, lacking verification of effectiveness and comprehensive short-term and long-term measures.