The U.S. Food and Drug Administration announced Wednesday that Sungwon Inc of Columbia, Md., corporation, and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction, which shuts down company operations.
Prior to entry of the consent decree, the company manufactured and distributed ready-to-eat Asian food products, including kimchi (the fermented Korean vegetable dish), and side dishes called ban chan, some of which contained seafood.
The consent decree restrains Sungwon from further food processing until it complies with the FDA’s current Good Manufacturing Practice (cGMP) regulations, the agency said in a news release. 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, in the agency’s prepared statement.
Following the most recent inspection of Sungwon by the FDA in October of 2010, Lee was presented with a 15-item list of violations, including 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 violations were similar to those observed by the FDA and the Maryland Department of Health and Mental Hygiene in previous inspections of the facility, the agency charged.
The company failed to correct the violations and comply with food safety laws, the FDA said.© Food Safety News