FDA 483 - US Foods, Inc. - August 22, 2025

An FDA inspection of US Foods, Inc.'s warehouse in Garland, TX, revealed significant deficiencies in plant sanitation and HACCP plan management. Observations included widespread food product spillage, damaged items, and an inadequate HACCP plan for shucked molluscan shellfish that failed to address Clostridium botulinum. Furthermore, the individual responsible for HACCP plan reassessment lacked the required training and qualifications.