Inspections, Compliance, Enforcement, and Criminal Investigations
Solar Farms, Inc. 11/4/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
November 4, 2009
VIA FEDERAL EXPRESS
Charles E. Dowse
Solar Farms, Inc.
140 South Woodside Parkway
West Columbia, SC 29170
Dear Mr. Dowse:
On July 16 through August 3, 2009, the Food and Drug Administration (FDA) conducted an inspection of your bean sprout processing facility located at 140 South Woodside Parkway in West Columbia, South Carolina. The inspection was initiated in response to the notification from the North Carolina Department of Agriculture on July 15, 2009, of a positive test for Listeria monocytogenes in your alfalfa sprouts identified with a Sell By date of 7/22/09. During the inspection we collected a variety of samples consisting of seeds, water, finished product and environmental swabs. The results of the analysis of the environmental swabs (sample number 558586) also found the pathogen Listeria monocytogenes in your facility. Based on the results of the laboratory analysis of the environmental swabs collected during the inspection and the objectionable conditions observed during the inspection, you are operating your processing facility in a manner which renders your sprout products adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or been rendered injurious to health. Reports of the analytical results of all samples collected, to include sample 558586, were mailed to you by the FDA Southeast Regional Laboratory.
You may find the Act and the Current Good Manufacturing Practice regulation for human food through links in FDA's home page at www.fda.gov.
Listeria monocytogenes (L. monocytogenes) is a pathogenic bacterium that is widespread in the environment and may be introduced into a food processing facility. L. monocytogenes can contaminate foods, resulting in a mild illness (called listerial gastroenteritis) or a severe, sometimes life-threatening, illness called invasive listeriosis. Immune-compromised individuals and unborn fetuses are particularly susceptible to Listeriosis. In the past, sprouts that are ready-to-eat (RTE) have been implicated in outbreaks of invasive listeriosis.
L. monocytogenes can be isolated from soil, silage and other environmental sources and can also be found in man-made environments such as food processing establishments. Any moist area, such as your sprout production areas, can harbor L. monocytogenes. This organism can grow at refrigeration temperatures. During our inspection, we documented conditions and practices that may lead to the contamination of your products with pathogens such as L. monocytogenes and may be conducive to pathogen growth in your products. As such, the products manufactured in that facility are adulterated within the meaning of Section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)], in that they have been prepared, packed, or held under insanitary conditions whereby they may have
been rendered injurious to health.
The following conditions were noted during the current inspection of your facility:
1. Your plant is not constructed in such a manner as to prevent condensate from contaminating food contact surfaces. Specifically there were air ventilation system vents with visible condensation directly over a three compartment sink and stainless steel table with trays in the alfalfa sprouting production room. You had identified condensate as a potential source of L. monocytogenes after our previous inspection.
2. You have failed to implement effective measures to exclude pests from the processing areas. On 7/16 a live cock roach was observed in the alfalfa sprout production room under an unused piece of equipment immediately adjacent to an active mung bean separator.
This letter is not an all inclusive list of violations that may exist at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act and applicable regulations. We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product(s) and or enjoin your firm from operating.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
During the inspection, our investigator noted that you are using a (b)(4) solution (b)(4) to presoak the seeds; however, you do not test the solution to assure that it is of the necessary strength to kill pathogens. In addition, our investigator observed that you do not test finished sprouts or spent irrigation water for microbial contaminants. Both of these practices are recommended for growers of raw, ready-to-eat sprouts in FDA's Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds. You can find FDA's guidance at the following website: http:/www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm
Please send your written reply to Philip S. Campbell, Compliance Officer, at the address noted in the letterhead. If you have any questions regarding this letter, you may contact Mr. Campbell at
Anne P. Reid, Acting Director