Butterball LLC – FDA EIR, Nov 7, 2018

An FDA comprehensive surveillance inspection of Butterball LLC's poultry feed mill in Columbus, Kansas, was conducted from November 6-7, 2018. This inspection, guided by Current Good Manufacturing Practice (CGMP) and Preventive Controls for Animal Food regulations (21 CFR Part 507), identified several key issues. The firm failed to adequately evaluate foreseeable hazards, specifically omitting Fumonisin as a potential contaminant in corn ingredients. Ineffective pest exclusion measures were observed, with multiple birds present in production and storage areas, and significant structural gaps allowing pest entry. Additionally, the facility's grounds were not maintained to prevent animal food contamination, evidenced by pooled water and mud at the unloading pit. A separate observation noted that the food safety plan had not been signed by the most responsible on-site individual, though this was corrected and verified during the inspection. The company's director acknowledged the uncorrected observations and committed to implementing corrective actions for the hazard analysis, pest control, and grounds maintenance issues. Management was reminded of their responsibility to comply with the Federal Food, Drug, and Cosmetic Act.