District Court Orders California Firm to Stop Manufacturing and Distributing Adulterated Food
A federal court permanently enjoined a food company in San Francisco from manufacturing and distributing adulterated food, the Department of Justice announced today.
In a complaint filed Nov. 22, 2019 at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that Golden Gate Soy Products Inc, violated the Federal Food, Drug and Cosmetic Act (FDCA) by manufacturing and distributing ready-to-eat tofu and other soy-based products, including marinated bean cake, soy milk, and tofu pudding, in a facility with chronic insanitary conditions. The complaint alleged that FDA inspections uncovered the prolonged presence of Listeria monocytogenes (L. mono) at the company’s facility, and that adequate measures were not put in place to reduce the risk of health hazards such as L. mono.
The complaint, filed in U.S. District Court for the Northern District of California, also named company owners/operators Yong Li Chen and Ling Hong Tang as defendants. All of the defendants agreed to be bound by a consent decree of permanent injunction filed with the complaint.
“Consumers should be able to trust that the food they eat is free of dangerous pathogens, like listeria,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice, working together with the FDA, does not hesitate to take action against food manufacturers and distributors when they fail to comply with consumer safety laws.”
“After documenting a pattern of food safety violations, the FDA worked with DOJ in order to prevent potentially contaminated food from reaching consumers. Listeria is a harmful pathogen and the company failed to take the appropriate corrective actions resulting in this action,” said FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. “Americans rely on the FDA to keep their food safe. When a company fails to follow the law, the FDA will take action to protect the public health.”
According to the complaint, three FDA inspections of the defendants’ facility — in September-October 2017, June 2018, and February 2019 — all uncovered violations of FDA food safety regulations. Although the defendants were advised numerous times of their violative practices and the need to take corrective action, inspectors continued to find L. mono in the facility.
The consent decree entered by the court permanently enjoins the defendants from violating the FDCA. Under the order, the defendants may not manufacture or distribute food until they comply with specific remedial measures. Among other requirements, the defendants must hire a qualified independent expert to develop an effective sanitation control program. Before manufacturing or distributing any food, defendants must first receive FDA’s written determination that their manufacturing practices comply with the law.
This matter was handled by Trial Attorney Meredith B. Healy of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Noah T. Katzen of the FDA’s Office of the Chief Counsel and the United States Attorney’s Office for the Northern District of California.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.