FDA WARNING_LETTER - Solar Farms, Inc. - August 03, 2009

The FDA conducted an inspection of your bean sprout processing facility in West Columbia, South Carolina, from July 16 to August 3, 2009. This inspection was prompted by a North Carolina Department of Agriculture notification of Listeria monocytogenes in your alfalfa sprouts. Environmental swabs collected during the inspection also tested positive for Listeria monocytogenes, indicating insanitary conditions. Consequently, your sprout products are deemed adulterated under Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)]. Key violations identified include: 1) The plant's construction does not prevent condensate from contaminating food contact surfaces, specifically noting condensation over a three-compartment sink and stainless steel table. 2) The firm failed to implement effective pest exclusion measures, evidenced by a live cockroach in the alfalfa sprout production room. Additionally, the investigator noted that the firm does not test the strength of the (b)(4) solution used for presoaking seeds, nor does it test finished sprouts or spent irrigation water for microbial contaminants, practices recommended by FDA's Guidance for Industry. The FDA requires a written response within fifteen working days outlining specific corrective actions, supporting documentation, and a timeline for completing any outstanding corrections. Failure to promptly address these violations may result in further regulatory action, such as product seizure or an injunction against the firm's operations.