| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human ServicesJanuary 7, 2011
WARNING LETTER NYK-2011-14
VIA U.P.S.
Mr. Sein Win
President
Snow White Food Products, Inc.
621 Bergen Street
Brooklyn, New York 11238-3405
Dear Mr. Win:
An inspection of your alfalfa sprout processing facility located at 621 Bergen Street, Brooklyn, New York was conducted on August 19 & 24, 2010 and September 1, 2010 by investigators of the U.S. Food and Drug Administration (FDA).
The above referenced inspection was conducted in response to a sample of your alfalfa sprouts collected by the United States Department of Agriculture under their Microbiological Data Program. The sample analyzed by the State of New York Department of Agriculture laboratory yielded Salmonella. Foods containing Salmonella are adulterated within the meaning of 21 Section 402(a)(1) [21 U.S.C. 342(a)(1)] of the Federal Food, Drug, and Cosmetic Act (the Act), in that the products contain a poisonous or deleterious substance which may render them injurious to health.
During our inspection, investigators documented conditions and practices that may lead to the contamination of your products with pathogens and may be conducive to pathogen growth in your products. These conditions cause the alfalfa sprouts manufactured, processed, and stored in your facility to be adulterated within the meaning of Section 402(a)(4) [21 U. S.C. 342(a)(4)] of the Act, in that your alfalfa sprouts have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.
The following insanitary conditions were observed:
- According to the thermometer in your cooler, the temperature in your cooler was 46ËšF. Finished sprouts should be refrigerated at or below 40ËšF to reduce the potential for growth of pathogens which may be present. Listeria monocytogenes is a pathogenic bacterium that grows at temperatures such as 46ËšF and can result in a severe illness called invasive listeriosis. Immune compromised individuals such as infants, the elderly, and transplant recipients are more susceptible. In pregnant women, listeriosis can lead to miscarriage or stillbirth. FDA recommends continuous temperature monitoring of ready-to-eat foods.
- The area between the tumbler and the drum quadrants had not been adequately cleaned and sanitized as evidenced by dirt and grime observed. These conditions can foster colonization of pathogens such as Listeria monocytogenes.
- The air intake for the fan used to agitate sprouts at the rinse vat bubbler brings in air from an area in which a dead mouse as well as dust and dirt were observed. These conditions create the potential for pathogens and dirt to be spread from the air to the sprouts.
- Two dead end pipes of approximately six to nine inches long were observed as part of the water supply system piping. We recommend that you eliminate these dead ends because of the potential for accumulation of stagnant water and other impurities posing a possible site for pathogen growth and accumulations.
- Hoses containing stagnant water were observed on the floor. These hoses are used to connect the water supply pipes to the sprout misting system. Pathogens or filth from the floor could get into the hoses and grow in the stagnant water and then be spread to the sprouts through the misting system. We recommend that you drain and sanitize these hoses and store them off the floor.
- The PVC pipe utilized to fill the rinse vat with potable city water terminates approximately 24 inches below the flood level of the vat providing no possible air gap. We recommend that you either add an air gap or a back flow prevention device because of the potential contamination from backflow.
We acknowledge the verbal commitment you made during the inspection to correct the conditions noted. The adequacy of any corrective actions will be assessed at our next inspection.
It is your responsibility to ensure that the sprouts you produce are not in violation of the Act. FDA recommends that you have detailed written Sanitation Standard Operating Procedures (SSOPs) to maintain your facility and equipment in a condition that will protect against contamination of the food and maintain control throughout all stages of sprout production. Equipment and floors should also be constructed in such a way that they may be adequately cleaned. We further recommend you document your activities and maintain records. You can find the Act through links in FDA's home page at www.fda.gov. In addition, you may wish to reference the FDA guidance document entitled "Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds," which is available at http://www.fda.gov/Food/GuidanceComplianceRegulatorylnformation/Guidance Documents/ProduceandPlanProducts/ucm120244.htm.
This letter may not list all the violations at your facility. You are responsible for ensuring that your facility and your products are 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 or 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.
Please send your written reply to the Food and Drug Administration, Attention: Lillian C. Aveta, Compliance Officer, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have any questions regarding this letter, please contact Ms. Aveta at 718-662-5576.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
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