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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Henrys Farm Inc. 8/2/12

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707

 

WARNING LETTER
CMS# 310598
 
August 2, 2012
 
Certified Mail
Return Receipt Requested
 
Mr. Soo Choul Park, President
Henry’s Farm Inc.
5500 Fair Oak Lane
Woodford, VA 22550
 
Dear Mr. Park:
 
We inspected your soybean sprout and mung-bean sprout manufacturing facility, located at 5500 Fair Oak Lane, Woodford, VA 22550 on April 30, May 1-4, and 10, 2012. This inspection was conducted in response to a sample of your of soy bean sprouts collected by the Virginia Department of Agriculture and Consumer Services (VDACS) and that yielded Listeria monocytogenes. In this letter we summarize violations we observed and set forth steps you may take to demonstrate your correction.
 
During the inspection, FDA collected samples of finished JJBS soybean sprout, P-Natto soybean sprout, and mung-bean sprout as well as environmental samples from your facility and your well water. We notified you with a letter dated June 5, 2012 that our laboratory analysis of sample 752567, which consisted of ten approximately 100-gram sub-samples of JJBS soy bean sprout product, yielded Listeria monocytogenes. Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections to pregnant individuals and individuals with weakened immune systems. We acknowledge your cooperation in recalling your soybean sprouts from the marketplace, ceasing of all production activities, and voluntarily disposing of all in-process products.
 
Our investigators also documented numerous insanitary conditions and practices that may have contributed directly or indirectly to contamination of your sprouts with pathogens and filth. Accordingly, the soybean sprouts and mung-bean sprouts grown in your facility are adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(a)(4)] because they have been prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health. 
 
Based on a review of labels, your soybean sprout and mung-bean sprout products packaged and sold in ten pound bags are misbranded within the meaning of Section 403 of the Act [21 U.S.C. §343] and the regulations for food labeling at Title 21, Code of Federal Regulations, Part 101 (21 CFR 101). You can find the Act and Code of Federal Regulations through links on FDA’s homepage at www.fda.gov.
 
Insanitary Conditions and Practices
 
The following insanitary conditions and practices were observed:

A.    There were numerous rodent pellets in bags of mung beans, as well as gnawing on 25 kg paper bags of soybeans located in your firm's refrigerated seed storage and on product in an additional shed located approximately 200 feet west of the refrigerated seed storage area containing an unknown amount of palletized soybeans. There was a foul odor consistent with rodent infestations associated with the shed. 

There were gaps under the doors in the refrigerated seed storage area and under and in between the doors leading into the sprout processing area. Further, raw soybeans were stored in a shed that had numerous gaps and holes in the ceiling. These gaps open to the exterior grounds and are large enough for rodents and other pests to gain ingress to the preparation, packing and storage areas. You store soybeans under these conditions where they may become contaminated with rodent feces and/or urine. Rodents are known vectors of pathogens.
 
B.     A hand-washing sink drained used water onto the floor. Used hand-washing water can be a source of pathogens and may contaminate products, processing equipment, and employees’ shoes. Because your employees enter the production room with unsanitized street shoes the water may facilitate the spread of any pathogens that come in on their shoes.
 
C.     The wash bin exit chute leading to the sprout air dryers and the packaging machine had an accumulation of debris on the inner stainless steel food contact surface located in the sprout processing area. There was also an accumulation of debris on the underside of the conveyor belt located above a conveyor belt on which soybeans are transported. We note that you do not use detergent for washing or any other surfactant to wash equipment and food contact surfaces used for manufacturing sprouts. Detergents or some kind of surfactant are necessary to remove food residues from surfaces. Food residues may harbor pathogens and, since they are on food contact surfaces, they may contaminate your food with pathogens.
 
D.    The metal mesh conveyor belt in the sprout processing area contains loose metal burrs, measuring approximately one (1) quarter of an inch in diameter. Sprouts pass over this belt and there is no subsequent metal detection step.
 
Misbranding charges
 
Your JJBS soybean sprouts and mung-bean sprouts are misbranded within the meaning of section 403(i)(1) of the Act [21 U.S.C. § 343(i)(1)] because these products fail to bear a label with a statement of identity as required by 21 CFR 101.3. They are further misbranded within the meaning of section 403(e) of the Act [21 U.S.C. § 343(e)] because the labels fail to bear the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5; and the labels fail to bear an accurate statement of the net quantity of contents in terms of weight, measure, or numerical count in accordance with 21 CFR 101.105.
 
The above items are not intended to be an all-inclusive list of the violations at your facility. It is your responsibility to ensure compliance with the applicable laws and regulations administered by FDA. You should take prompt action to correct these violations. Failure to do so may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and/or injunction.
 
Next Steps
 
We request that you and/or your representatives appear for a meeting at FDA’s Baltimore District Office. We have tentatively scheduled September 6, 2012 at 10:30 AM as the meeting date and time at FDA’s Baltimore District Office. The Baltimore District office is located at 6000 Metro Drive, Suite 101, Baltimore, MD 21215. Personnel from the Virginia Department of Agriculture and Consumer Services (VDACS) will also be participating. Please be prepared to discuss the steps you and your firm have taken to address the observations cited during our May 2012 inspection. Be prepared to provide documentation, photographs or other relevant information to support the corrections you have implemented.
 
Information on proper handling and controls for sprout manufacturing can be found in our Guidance for Industry: Reducing Microbial Food Safety Hazards for Sprouted Seeds, (located online at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120244.htm) and Guidance for Industry: Sampling and Microbial Testing of Spent Irrigation Water During Sprout Production (located online at http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/ProduceandPlanProducts/ucm120246.htm), both dated October 27, 1999. Also, the California Department of Public Health, Food and Drug Branch has posted a series of online videos related to sprout safety that can be found at: http://postharvest.ucdavis.edu/libraries/video/. The documents and online videos are considered guidance and are designed to assist you in complying with the Food, Drug, and Cosmetic Act.
 
We look forward to meeting with you and/or your designee. Please contact Compliance Officer Ernest Bizjak by calling (410) 779-5715 or emailing ernest.bizjak@fda.hhs.gov to confirm the meeting date and time, or if you have any questions. 


 
Sincerely yours,
/S/             
Evelyn Bonnin
District Director
Baltimore District Office