FDA 483 - J.M. Smucker LLC - July 08, 2025

The U.S. Food and Drug Administration (FDA) issued a Form 483 to a food manufacturing firm (company name not specified in the document) following an inspection conducted from June 9 to July 8, 2025. The primary observation cited a failure to adequately clean and sanitize utensils and equipment used in peanut butter processing, which could lead to product contamination. Specifically, the interior, food-contact surfaces of equipment, including pipes, mills, homogenizers, finishers, and fillers, were not subject to proper sanitation operations. A routine 'wash' procedure was utilized to clear product lines but was explicitly stated by operations management as not intended for sanitation. Furthermore, the Quality Director confirmed that equipment was not regularly disassembled for cleaning of food-contact surfaces, even in response to presumptive positive finished product samples. In such cases, only the non-sanitation 'wash' was conducted, demonstrating a systemic deficiency in addressing potential contamination. This practice indicates potential non-compliance with the Federal Food, Drug and Cosmetic Act, which mandates the preparation and handling of food under sanitary conditions. The firm is required to implement robust corrective actions to ensure comprehensive cleaning and sanitation protocols are established and followed, thereby preventing contamination and ensuring product safety.