FDA WARNING_LETTER - RZM Food Factory - June 27, 2013

The FDA conducted an inspection of RZM Food Factory in Makawao, Hawaii, from June 25-27, 2013, documenting insanitary conditions and practices that render mung bean, clover, alfalfa, and radish sprouts adulterated under section 402(a)(4) [21 U.S.C. 342(a)(4)] of the Federal Food, Drug and Cosmetic Act. Key violations included the firm's admission that sprout trays, utensils, and processing equipment are only rinsed, not washed or sanitized, with visible residue and deteriorated surfaces like a pitted cement wash-trough. Additionally, the irrigation water tank was found corroded with flaking rust, open, and unprotected from pests, potentially contaminating the water supply. General housekeeping deficiencies, such as water-filled containers and empty cardboard boxes, created pest harborage areas. The FDA requires prompt corrective action to address these violations and prevent recurrence. A written response detailing specific actions and timelines is due within 15 working days. Failure to comply may lead to regulatory actions, including product seizure, injunction, and re-inspection fees. Guidance on sprout safety was provided.