Federal court orders Minnesota sprout and noodle company to cease operations due to unsanitary conditions
The U.S. Department of Justice brought the action on behalf of the FDA. The complaint that accompanied the consent decree alleges that Kwong Tung Foods, Inc. has an extensive history of operating under unsanitary conditions in violation of current Good Manufacturing Practice (cGMP) regulations and the FD&C Act. The FDA conducted multiple inspections, most recently in 2014 and 2015, and the FDA investigators observed repeated unsanitary conditions, including, rodent excreta pellets too numerous to count, improper cleaning, mold-like substances on equipment, failure to prevent cross-contamination from allergens and improper employee sanitation practices. Despite receiving a Warning Letter and participating in regulatory meetings with the FDA, Kwong Tung Foods, Inc., and Victor and Juney Wang failed to take adequate corrective actions to ensure the safety of their food. Additionally, the FDA worked with the Minnesota Department of Agriculture (MDA) to resolve this matter.
“The FDA expects food companies to follow cGMP regulations, and when a company does not address violations and sanitary protocols are being neglected, it poses potentially hazardous conditions,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA is taking the necessary actions to protect consumers and the U.S. food supply.”
Food, especially produce, is vulnerable to contamination with pathogenic microorganisms if exposed to unsanitary conditions during growing, harvesting, packing, holding or manufacturing, processing or transportation. Rodents in a facility are an additional cause for concern as they can sometimes carry and transfer bacteria and pathogenic microorganisms, like Salmonella, onto food. Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
As a result of this action, Kwong Tung Foods, Inc. is prohibited from directly or indirectly receiving, processing, manufacturing, preparing, packing, holding, and/or distributing any article of food at or from its facility. If Kwong Tung Foods Inc. intends to resume operations, the company must notify the FDA, and, among other requirements, retain an independent food safety expert to ensure Kwong Tung Foods, Inc. has and implements, to the FDA’s satisfaction, an appropriate written Sanitation Control Program. If it resumes operations, Kwong Tung Foods, Inc. must also retain an independent laboratory to conduct analyses of its food processing environment and food products, and provide employee training on sanitation and appropriate food handling techniques.
Although no illnesses have been reported in connection with Kwong Tung Foods Inc., consumers with complaints about any FDA-regulated products can report problems to their district office consumer complaint coordinator.
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.