FDA NEWS RELEASE
For Immediate Release: June 22, 2011
Media Inquiries: Tamara Ward, 301-796-7567, Tamara.Ward@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA: Maryland food manufacturer enters into consent decree
Company will shutdown to fix insanitary practices that led to government action
The U.S. Food and Drug Administration announced that Sungwon Inc of Columbia, a Columbia, Md., corporation, and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction.
Prior to entry of the consent decree, defendants manufactured and distributed ready-to-eat Asian food products, including kimchi (a fermented Korean vegetable dish), and side dishes called ban chan, some of which contain seafood.
The consent decree restrains Sungwon Inc of Columbia, and Mrs. Lee from processing food until the company complies with the FDA’s current Good Manufacturing Practice (cGMP) regulations. The company also is restrained from processing seafood until it complies with the seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
"By imposing this injunction, the FDA is helping to prevent health risks for consumers of certain seafood products,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “Until Sungwon meets the current good manufacturing practice requirements for foods and the seafood Hazard Analysis and Critical Control Point regulations it will no longer be able to process or distribute their products."
During the agency’s most recent inspection in October of 2010, FDA investigators issued to Mrs. Lee a 15-item list of inspectional observations. The violations included failure to exclude pests from the food processing area to prevent contamination with bacteria and filth, and failure to have and implement adequate written seafood HACCP plans. The defendants failed to comply. The violations are similar to those observed by the FDA and the Maryland Department of Health and Mental Hygiene in previous inspections of the facility.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.