The U.S. District Court for the Northern District of California entered a consent decree of permanent injunction against Kun Wo Food Products Inc. (Kun Wo) and the firm’s co-owners, Zi Xing Liu and Zi Cheng Liu, to prevent the distribution of adulterated rice noodles, the Department of Justice announced today.
The department filed a complaint in the Northern District of California on April 12, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants have a history of processing rice noodles under insanitary conditions. As detailed in the complaint, the company prepared, processed, manufactured, packed, held and distributed rice noodles to local customers in the San Francisco area. The complaint alleged that Zi Xing Liu has ultimate authority over all of the firm’s operations, including financial expenditures, production processes and employee supervision and that Zi Cheng Liu shares responsibility with Zi Xing Liu for the firm’s production processes and is also responsible for product distribution.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and to be bound by a permanent injunction. As part of the settlement, the defendants represented that they have ceased receiving, preparing, processing, packing, holding, or distributing any type of food at or from any location. Under the permanent injunction, if the defendants seek to resume such activity, they must first inform FDA, take specific steps to improve the firm’s manufacturing practices, and then receive written approval from FDA.
“Kun Wo Food Products was repeatedly informed that the sanitation practices at its facility were deficient,” said Principal Deputy Assistant Attorney Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to aggressively pursue food companies and individuals responsible for the production of food under insanitary conditions in order to protect the American people and make sure America’s food supply is safe.”
According to the complaint, a 2016 inspection by FDA documented that defendants failed to take all necessary precautions to prevent food handlers from contaminating food with microorganisms or foreign material. For example, as alleged in the complaint, an employee used the vat containing rice soaking for the day’s production to rinse her bare hands after handling equipment. In addition, as noted in the complaint, during a 2015 inspection, FDA documented employees using the vat containing soaking rice to rinse their bare hands, rags and buckets after using the rags and buckets to clean the production area with detergent. The complaint also alleged that employees touched dirty equipment and then used their bare, unwashed hands to grab rice noodles for packaging. The complaint further alleged that during the most recent inspection, FDA found that machines used to steam, cool, slice and weigh the rice noodles were covered in grease and grime, causing the first sheet of rice noodles coming off the production machine to contain particulate matter.
According to the complaint, the most recent inspection also found that condensate dripped from a hose suspended from the ceiling into the vat containing soaking rice. Also, as noted in the complaint, condensate dripped from a copper pipe, with a green and black film on its surface, into a grinder containing rice for processing.
Further, the complaint alleged that during the 2015 inspection, FDA swabbed various surfaces in the firm’s production area, including the buckets used during processing and found the presence of bacterial contamination at the facility — L. mono was identified on the exterior of one bucket and L. seeligeri was found on the exterior of another bucket. The complaint alleged that the firm’s employees routinely submerged these buckets in the water that contained soaking rice.
L.mono is the bacterium that causes the disease listeriosis. The most serious forms of listeriosis can cause meningitis and septicemia. L. seeligeri does not cause disease; however, it is a marker indicating that conditions are favorable for the survival and growth of L. mono.
Under federal law, food processors are required to comply with current good manufacturing practices provided by FDA regulation. Failure to follow such regulations renders food adulterated under the Federal Food, Drug, and Cosmetic Act. In this matter, the complaint alleged that defendants violated the law by causing food to become adulterated while it was held for sale after shipment of one or more of its components in interstate commerce.
The government is represented by trial attorney Kathleen Konopka of the Civil Division’s Consumer Protection Branch, with the assistance of Senior Counsel Claudia Zuckerman of the U.S. Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.