Inspections, Compliance, Enforcement, and Criminal Investigations

Good Seed, Inc. 12/2/15

  

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 # 476745
 
December 2, 2015
 
VIA UPS
 
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 and packaging operation 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 Listeria monocytogenes (L. monocytogenes), a human pathogen FDA investigators also documented conditions and practices that are reasonably likely to have resulted in the contamination of your product with L. monocytogenes. 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. A swab taken from this location yielded L. monocytogenes.
 
The Virginia Department of Agriculture and Consumer Services (VDACS) collected finished product samples that yielded a strain of L. monocytogenes that is indistinguishable by PFGE analysis from the strain we isolated from the environmental sample we collected. These findings and observations demonstrate that L. monocytogenes from the environment may have contaminated your product. Accordingly, sprouts grown and packed in your Springfield, Virginia location 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.
 
L. 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 foodbome 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.
 
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 david.rice@fda.hhs.gov.
 
 
Sincerely,
/S/                                                           
Evelyn Bonnin
District Director
Baltimore District Office

Page Last Updated: 06/16/2016
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