FDA WARNING_LETTER - KJ3 Inc., DBA Rainier Sprouts - December 22, 2014

The FDA conducted an inspection of a sprouting operation in Tacoma, Washington, in December 2014, documenting insanitary conditions that render mung bean and soybean sprouts adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Despite the firm's January 2015 corrective action response to the FDA-483, several issues remained unaddressed. Violations included condensate dripping from the ceiling in critical areas, widespread rodent excreta pellets indicating inadequate pest control, and significant residues and gouges on conveyor equipment, demonstrating deficient cleaning and sanitizing practices. The presence of Listeria welshimeri in finished sprouts further confirmed inadequate sanitation and conditions conducive to pathogenic Listeria monocytogenes. The firm's responses were deemed insufficient, lacking commitment to halt production during repairs, documentation for pest control resolution, and procedural changes for ongoing equipment maintenance. The FDA requires the firm to take prompt action, provide a written response within fifteen business days detailing specific corrective steps, supporting documentation, and a timetable for any delayed actions. Failure to comply may lead to legal action, including seizure and injunction, and re-inspection fees.