Washington, DC - The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction on Friday, June 24, between the U.S. Food and Drug Administration and Wa Heng Dou-Fu & Soy Sauce Corp. requiring the business to immediately cease manufacturing and distributing food until it comes into compliance with federal food safety laws.
The company, owned by Peng Xiang “Martin” Lin and Yuexiao “Opal” Lin, and doing business as Wa Heng Dou-Fu & Soy Sauce International Enterprises out of Sacramento, California, distributes soy products, including tofu and soy drink.
Legal action was sought after the FDA documented repeated violations of federal food safety laws. As alleged in the complaint, during a 2015 inspection, FDA investigators observed several food safety violations including: inadequate hand washing, improperly cleaned equipment, and failure to take necessary precautions to protect against contamination of food and food contact surfaces. These violations were repeat observations from previous inspections by the FDA, which received assistance from the California Department of Public Health. The FDA also identified several environmental samples taken from the company’s facility that tested positive for Salmonella.
“Salmonella in a food facility is a public health risk and is one of the most common causes of foodborne illness,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “When a company continues to violate federal food regulations, the FDA must take necessary action to protect public health.”
Salmonella is a pathogenic organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer short-term symptoms such as severe diarrhea, bloody diarrhea, fever, chills, abdominal discomfort, and occasionally vomiting.
As a result of this court action, Wa Heng Dou-Fu & Soy Sauce Corp. is prohibited from directly or indirectly receiving, preparing, processing, manufacturing, labeling, packing and/or distributing any articles of food. If the company intends to resume operations, it must, among other things, retain an independent expert to develop a pathogen control program, conduct microbial and pathogen testing of the company’s facility, and provide employee training on sanitary food handling techniques. If the FDA determines that the company may resume operations, the consent decree requires the company to conduct periodic, independent audits to ensure ongoing compliance.
No illnesses have been reported in connection with Wa Heng Dou-Fu & Soy Sauce Corp. Consumers are encouraged to contact the FDA to report problems with FDA-regulated products.
The U.S. Department of Justice brought the action on behalf of the FDA. The FDA also worked with the California Department of Public Health on the case..
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..