FDA WARNING_LETTER - Naumes Inc - September 22, 2025

On January 21, 2026, the FDA issued a warning letter to Naumes, Inc. following an inspection of its Medford, Oregon facility conducted from September 15 to September 22, 2025. The inspection identified serious violations of the Produce Safety regulation (21 CFR Part 112), resulting in the company’s pears being classified as adulterated under the Federal Food, Drug, and Cosmetic Act. The primary violations involved a failure to maintain the sanitary quality of water used during harvesting and packing. Specifically, investigators observed harvest bins contaminated with vegetative debris being submerged in recirculated water, a repeat violation from 2023. Additionally, the company failed to handle produce in a way that prevents contamination, as harvest bins were placed directly on the ground, allowing debris to contact the fruit. The FDA also noted that the company’s agricultural water risk assessments were incomplete and failed to document necessary mitigation measures for overhead irrigation hazards. While Naumes, Inc. submitted several corrective action plans, the FDA found them insufficient due to missing documentation and a lack of clear thresholds for water safety. The company must provide a written response within 15 working days outlining its completed and planned corrective actions. Continued failure to comply may result in legal action, such as product seizure or injunction.