FDA 483 - Sanfilippo John B & Son Inc - July 15, 2025

An FDA inspection conducted at John B. Sanfilippo & Son, Inc. from July 14-15, 2025, identified significant deficiencies in sanitation, facility design, and pest control. Inspectors observed widespread issues with equipment cleaning, including black and old product residue, along with leaking gaskets on machinery and framework within the peanut butter and roasted peanut production areas. These conditions indicate a failure to adequately clean and sanitize utensils and equipment, posing a risk of food contamination and microbial biofilm development.

The facility's design was also found to impede sanitary operations, evidenced by active condensation dripping from overhead chilled water pipes in the ingredient/finished product warehouse. This could lead to microbial contamination and cross-contamination. Furthermore, the firm failed to effectively exclude pests, with gnats, flies, and moths observed flying and landing on surfaces in both the warehouse and peanut butter production area, including near exposed product. These observations suggest potential non-compliance with the Federal Food, Drug, and Cosmetic Act, particularly concerning insanitary conditions that could result in contaminated food products. John B. Sanfilippo & Son, Inc. is expected to implement comprehensive corrective actions to address these issues and ensure compliance with regulatory standards.