FDA WARNING_LETTER - Tiny Greens - January 28, 2011

The FDA conducted an inspection of Tiny Greens' sprouting facility from December 2010 to January 2011, prompted by a Salmonella enterica serotype outbreak linked to their sprouts, which sickened individuals across multiple states. An environmental sample from compost pile runoff outside the facility yielded a strain of Salmonella indistinguishable from the outbreak strain. As a result, the sprouts were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Observed violations included compost runoff pooling near the greenhouse entrance, with employees and carts moving through it into production areas without cleaning, posing significant cross-contamination risks. Other deficiencies noted were a leaking handwash sink creating wet conditions, rinsing equipment near open sprouts causing splashing, germination drum doors stored on the floor and not cleaned before use, and water splashing onto sprout pails from dolly wheels during transfer. Additionally, the firm's seed treatment method was found not to be in accordance with label directions and lacked evidence of equivalence. The FDA found the firm's proposed corrective actions inadequate, specifically regarding cart cleaning and the leaking sink. Tiny Greens is required to provide a written response within 15 working days detailing specific corrective actions, preventative measures, and a timeline, with documentation. Failure to promptly correct these violations may lead to legal action, including seizure and injunction. The FDA also provided guidance on compost treatment and seed sanitization methods.