Md. Kimchi Maker Agrees to Close After Receiving FDA Citation for Insanitary Practices

The consent decree prohibits the company and its owner from processing food or seafood until it complies with pertinent regulations.

The U.S. Food and Drug Administration announced that Sungwon Inc. of Columbia, Md., and the company’s president, Sang Ja Lee, have signed a consent decree of permanent injunction.

Before entering 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. and 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 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.


Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Comply with OSHA’s Electronic Recordkeeping Requirements

    Collect relevant incident data and generate accurate OSHA 300, 300A, and 301 regulatory reports, including 300A CSV files for easy electronic submission to OSHA.

  • Complete Online Safety Training Courses

    Deliver state-of-the art, online safety training courses to your organization with IndustrySafe Training Management Software. Generate reports to track training compliance and automatically notify learners of upcoming or overdue classes.

  • Easy to Use Safety Inspection App

    Conduct inspections on the go with IndustrySafe’s mobile app. Complete safety audits at job sites and remote locations—with or without web access.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus