Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Baltimore District Office
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5455
FAX: (410) 779-5707
CMS # 476745
August 17, 2015
Mr. Kyu Cheol Chung, Owner
Good Seed, Inc.
7954 F-H Twist Lane
Springfield, VA 22153
Dear Mr. Chung:
The United States Food and Drug Administration (FDA) conducted an inspection of your growing, processing, and packaging facility of soybean and mung bean sprouts, located at 7954 F-H Twist Lane, Springfield, VA 22153, from June 1, 2015 through June 3, 2015. During the inspection, FDA investigators collected environmental samples consisting of multiple swabs taken from various areas within your firm. FDA laboratory analysis of the environmental swabs found the presence of human pathogen Listeria monocytogenes. Analysis using Pusled-Field Gel Electrophoresis (PFGE) showed that the one (1) confirmed FDA environmental swab matched the strain of Listeria monocytogenes found from the Virginia Department of Agriculture and Consumer Services (VDACS) physical samples.The presence of Listeria monocytogenes in your facility is significant in that it demonstrates the sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food.
Additionally, FDA investigators observed serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 110). Based on FDA’s analytical results from the environmental sample and the inspectional findings documented during the inspection, we have determined that your food products 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), in that they were prepared, packed or held under insanitary conditions whereby they may have been rendered injurious to health. You can find the Act and FDA’s regulations through links in FDA’s home page at www.fda.gov.
FDA laboratory analysis of the environmental sample collected on 06/01/2015, confirmed that one (1) of the 73 environmental swabs was positive for Listeria monocytogenes. The positive swab was collected from a food contact surface located on the staging bin along the 1 pound sprout bagging machine. Analysis using Pulsed-Field Gel Electrophoresis (PFGE) showed that the one (1) confirmed FDA environmental swab matched the strain of Listeria monocytogenes found from the Virginia Department of Agriculture and Consumer Services (VDACS) physical samples.
Listeria monocytogenes is a pathogenic bacterium that is widespread in the environment. It can proliferate in food processing facilities without proper controls, where it may contaminate food. Consuming these contaminated foods can lead to a severe, sometimes life-threatening illness called listeriosis: an atypical foodborne illness of major public health concern due to the severity of the disease, its high case-fatality rate, long incubation, and predilection for individuals with underlying conditions.
You failed to report a reportable food to the Reportable Food Registry (RFR) within twenty-four hours of determining that an article of food is a reportable food for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals, as required by section 417(d)(1) of the Act [21 U.S.C. § 350f(d)(1)]. Specifically:
- On May 8, 2015, June 22, 2015, and August 3, 2015 your firm voluntarily recalled all packages of soybean sprouts and mung bean sprouts because they have the potential to be contaminated with Listeria monocytogenes. The contamination was discovered through surveillance monitoring coordinated by the Virginia Rapid Response Team (RRT), Virginia Department of Agriculture and Consumer Services (VDACS) and testing by the Virginia Division of Consolidated Laboratory Services revealed the presence of Listeria monocytogenes in the product. No RFR was filed about these products after the three (3) recalls.
The Reportable Food Registry was established by section 1005 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-085) to provide a reliable mechanism to track patterns of adulteration in food in order to support efforts by FDA to target limited inspection resources to protect the public health. It requires a responsible party to file a report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.” The responsible party is the person who submits the registration under section 415(a) of the Act [21 U.S.C. § 350f(d)] for a food facility that is required to register under section 415(a), at which such article of food is manufactured, processed, packed, or held. Failure to submit a required report about a reportable food is a prohibited act under section 301(mm) of the Act [21 U.S.C. § 331(mm)].
Additionally, FDA investigators also observed the following violation of the Current Good Manufacturing Practice regulation for foods [21 CFR 110]:
1) Failure to clean food-contact surfaces as frequently as necessary to protect against contamination of food, as per 21 CFR 110.35(d). During the current inspection, food particles were observed on the hopper section and conveyor belt of your one (1) pound bagging machine that had been cleaned and sanitized the day prior. This FDA observation cited food particles directly on the hopper area where FDA received a positive Listeria monocytogenes environmental sample.
We acknowledge your written 483 response, received on June 15, 2015, which described your corrective actions. Your response indicated that the observed food particles have been removed, and the machinery will be washed, scrubbed, and thoroughly inspected after cleaning is performed. Your response does not provide sufficient details for FDA to evaluate the adequacy of your corrective actions. You did not provide a detailed description of the specific type of sanitizer being used, how it will be used, or if any extensive cleaning was performed by taking apart the machinery or replacing specific parts.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations. You should include in your response any pertinent photography of corrections, RFR filing, 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.
Additionally, Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your reply to the U.S. Food and Drug Administration, Attention: David P. Rice, Compliance Officer at the address above. If you have questions regarding any issues in this letter, please contact Mr. Rice via telephone at (410) 779-5463 or email at firstname.lastname@example.org.
Baltimore District Office