The U.S. District Court for the Eastern District of California entered a consent decree of permanent injunction against Wa Heng Dou-Fu & Soy Sauce Corporation doing business as Wa Heng Dou-Fu & Soy Sauce International Enterprises (Wa Heng) and the firm’s co-owners, Peng Xiang “Martin” Lin and Yuexiao “Opal” Lin, to prevent the distribution of adulterated and misbranded soy products, the Department of Justice announced today.
The Department filed a complaint in the Eastern District of California on June 17, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants violated the Food, Drug and Cosmetic Act by causing food that is held for sale after shipment of one or more of its components in interstate commerce to become adulterated and misbranded. According to the complaint, the defendants have an extensive history of operating their food manufacturing facility under insanitary conditions, failing to follow current good manufacturing practice requirements and misbranding their food products.
As detailed in the complaint, the company receives, prepares, processes, manufactures, packs, labels, holds and distributes soy products including fried tofu, firm tofu, seasoned tofu and soy drinks. The complaint alleged that Martin Lin’s responsibilities include the firm’s daily operations, raw material purchases, facility and equipment maintenance and production schedule and that Opal Lin’s responsibilities include training employees and overseeing employee performance.
In conjunction with the filing of the complaint, the defendants agreed to settle the case and to be bound by a permanent injunction that requires Wa Heng to cease all food preparation, manufacturing and distribution. If the defendants seek to resume preparing, manufacturing and distributing food, they must implement remedial measures set forth in the injunction, notify FDA of the measures taken, and receive written notification from FDA that they appear to be in compliance with the remedial requirements set forth in the injunction and the Food, Drug and Cosmetic Act.
According to the complaint, the defendants had a history of repeated violations. A 2015 inspection by FDA documented that the defendants failed to take reasonable precautions to ensure that production procedures do not contribute to contamination from any source. For example, as alleged in the complaint, FDA observed at least three employees spraying pressurized water from a water hose onto the production area floor, where FDA isolated Salmonella Havana, causing water to splash from the floor onto uncovered tofu and onto food contact surfaces, such as tofu presses and a filtration table. This was a repeat observation from the FDA’s 2012 inspection. In addition, FDA observed employees touching the bottoms of buckets and crates that had been on the floor and then touching tofu. The hand wash sink in the production room had no hot water because the valve had been turned off and the sink was inaccessible due to crates in front of it. This was also a repeat observation from the 2012 inspection.
According to the complaint, the most recent inspection also found that the defendants failed to maintain equipment and utensils in an acceptable fashion through appropriate cleaning and sanitizing. FDA observed spray hose nozzles, air valves, water valves and light switches that contained heavy residue, as well as a tofu cutting knife that was placed on top of a tofu press with greenish-brown buildup and then used to slice tofu.
Further, the complaint alleged that during the 2015 inspection, FDA conducted environmental sampling of the facility and five subsamples tested positive for pathogenic Salmonella Havana. According to the complaint, the positive samples were taken from, among other places, a floor drain near a cooking tank, a caster wheel on a cart carrying tofu and the floor between the packing and processing rooms. As noted in the complaint, FDA isolated a nearly identical strain of SalmonellaHavana during its 2011 and 2012 inspections.
During the 2015 inspection, FDA also collected samples of the defendants’ product labeling. The complaint alleges that the defendants’ products are misbranded because, among other things, some of the firm’s soy products fail to include a label containing an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.
