FDA 483 - SFD Opco, LLC - July 29, 2025

An FDA inspection of a freeze-dried raw pet food manufacturer located in Seward, NE, was conducted between July 21 and July 29, 2025. The inspection identified critical observations concerning the firm's food safety practices. The main violations included a failure to identify and implement adequate preventive controls to minimize or prevent hazards. Specifically, the company produces and distributes single-ingredient, freeze-dried pet treats made from beef liver and salmon without a validated pathogen reduction step, such as high-pressure pasteurization, which is necessary to ensure product safety. Additionally, the firm's verification methods for its preventive controls were found to be insufficient. The finished product sampling program for pathogens like Salmonella and Listeria was deemed inadequate because samples were not representative of the entire production lot, hindering the ability to effectively demonstrate the control measures' efficacy. These observations highlight the need for the manufacturer to establish comprehensive preventive controls and implement a robust, representative product testing program, consistent with FDA's food safety regulations. The company is expected to address these findings by developing and implementing appropriate corrective actions.