FDA 483 - US Foods, Inc. - Ft. Mill Division - August 22, 2025

During an FDA inspection conducted from August 20-22, 2025, at Warehouse w/ Seafood, several significant observations were noted, indicating non-compliance with food safety regulations.The primary concerns revolved around the facility's sanitation and its Hazard Analysis and Critical Control Point (HACCP) plan for seafood products. Inspectors observed that the plant was not maintained in a clean and sanitary condition. Specifically, widespread food product spillage, including rice, sugar, flour, and produce, along with broken pallets, was evident throughout the ambient and cooler storage sections. Issues also included loose produce, damaged and expired products commingled with dissimilar items, and unlabeled goods, all contributing to potential cross-contamination and insanitary conditions.Furthermore, the company's HACCP plan for shucked molluscan shellfish was found to be deficient. The plan failed to identify Clostridium botulinum growth and toxin formation as a potential hazard for refrigerated oysters, and the stated critical limit for temperature control was deemed inadequate to manage this risk effectively. Compounding this, the individual responsible for reassessing the HACCP plan, Isaak Torrez, lacked documented proof of successful completion of Seafood HACCP training, raising concerns about the plan's validity and implementation.These observations, documented on an FDA Form 483, require Warehouse w/ Seafood to implement prompt and effective corrective actions to ensure compliance with the Federal Food, Drug, and Cosmetic Act and established food safety principles for the storage and distribution of food and fishery products.