jang soo farm inc. – FDA Warning Letter, Sep 26, 2011

The FDA conducted an inspection of Jang Soo Farm, Inc. dba Rainier Sprouts, Inc. from August to September 2011, in response to industry-wide surveillance for pathogen contamination of sprouts. The inspection revealed insanitary conditions and practices, including the presence and activity of rodents and insects, leading to the determination that sprouts grown at the facility are adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Key violations included insanitary food contact surfaces, potential for employee cross-contamination due to poor hand-washing sink drainage and personal belongings near food, and facility conditions allowing filth into food, such as live rodents, rodent excreta, rust, condensation dripping into sprouts, and dirty fan blades. Additionally, the firm's seed treatment method was not in accordance with FDA recommended guidance of using 20,000 ppm calcium hypochlorite solution. While some corrective actions were acknowledged, their adequacy will be verified in a future inspection. The firm is required to respond within fifteen working days, detailing specific corrective actions, documentation, and a timetable for full implementation to prevent further regulatory action, including seizure or injunction.