FDA 483 - Eurofins Donor & Product Testing Inc Dallas - November 25, 2019

VRL Eurofins in Dallas, TX, a testing laboratory, was inspected by the FDA from November 20-25, 2019. The inspection revealed a significant issue regarding the firm's failure to investigate approximately 15 temperature excursions in storage freezers containing donor samples and reagents. This deficiency in deviation investigation, particularly concerning CGTP requirements, was noted as a repeat observation from a prior inspection.