San Francisco, California - The U.S. District Court for the Northern District of California entered a consent decree of permanent injunction against Fong Kee Tofu Co. Inc., Yan Hui Fong, the firm’s co-owner and chief executive officer, and Jen Ying Fong and Suny Fong, co-owners and corporate officers, to prevent the distribution of adulterated tofu and other soy food products, the Department of Justice announced today.
The department filed a complaint in the Northern District of California on Jan. 23 at the request of the U.S. Food and Drug Administration (FDA). The complaint alleges that the defendants have a history of processing soy food products under insanitary conditions. As detailed in the complaint, the company receives, prepares, processes, manufactures, labels, packs, holds and distributes soy food products including soy drinks, firm tofu, soft tofu, fried tofu balls (oil bean cake) and soybean cake. The complaint also alleges that Yan Hui Fong, Suny Fong and Jen Yin Fong are Fong Kee Tofu’s corporate officers with the authority and responsibility for preventing and correcting violations of federal law at the company.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and to be bound by a permanent injunction that requires Fong Kee Tofu to cease all operations and requires that if the defendants wish to resume manufacturing and distributing food in the future, the FDA first must determine that the firm’s manufacturing practices have come into compliance with the law.
“Fong Kee Tofu was repeatedly informed that the sanitation practices at its facility were deficient,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division. “The failure to make sure that its facility was operating under sanitary conditions could be a serious risk to the public health and needed to be remedied.”
According to the complaint, FDA inspectors in 2014 observed pigeons on top of plastic-wrapped raw soybean pallets and they observed insects flying around the area used to process firm tofu. The complaint further alleges that employees were observed using utensils that had not been properly sanitized in food production and packing tofu without washing or sanitizing their hands after coming into contact with insanitary objects. In addition, according to the complaint, residue was observed on equipment used in processing tofu even after the equipment had been cleaned. Under federal law, food manufacturers are required to comply with current good manufacturing practices to ensure that all food distributed into interstate commerce is not adulterated.
The government is represented by Counsel Melanie Singh of the Civil Division’s Consumer Protection Branch, with the assistance of Associate Chief Counsel for Enforcement Deeona Gaskin of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.
