The Department of Justice announced today that the U.S. District Court for the Eastern District of New York entered an injunction against Foo Yuan Food Products Company Inc. (Foo Yuan) of Long Island City, New York, its owner and president Hsing Chuang, and its secretary Susan Chuang. The injunction permanently enjoins the defendants from preparing, processing, and distributing food products without first taking required remedial action designed to protect consumers from adulterated fish and fishery products.

The injunction stems from a complaint the Department filed in the U.S. District Court for the Eastern District of New York on Aug. 20, 2018, at the request of the U.S. Food and Drug Administration (FDA). The complaint alleged that the defendants prepare, pack, hold and distribute refrigerated and frozen ready-to-eat fish balls, fried fish cakes and fried fish balls. According to the complaint, the defendants failed to adequately control the risk of Clostridium botulinum and Listeria monocytogenes (L. mono.) growth and toxin formation in susceptible fish and fishery products.

“The Department of Justice is committed to enforcing federal laws designed to ensure food safety,” said Assistant Attorney General Jody Hunt of the Department of Justice’s Civil Division. “The Department of Justice works together with the FDA to ensure that Americans are protected from potentially unsafe food.”

“The defendants’ failure to respond to the serious allegations in the government’s civil complaint was in keeping with their failure to follow FDA regulations in place to protect the public from adulterated fish products,” said U.S. Attorney Richard P. Donoghue for the Eastern District of New York. “The injunction ensures they are out of business until they can comply with all applicable laws and regulations.”

The District Court’s order permanently enjoins defendants from preparing, processing, and distributing food products without first taking required remedial action set forth in the District Court’s order. The measures include, among other things, retaining an independent expert to assist with remedial efforts, including development and implementation of a Listeria Monitoring Program. In addition, defendants’ expert must conduct hazard analyses and develop a written Hazard Analysis and Critical Control Point plan for each type of fish or fishery product prepared, processed, or distributed by defendants to effectively control food safety hazards.

FDA inspected Foo Yuan’s facility in 2014, 2016 and from December 2017 to January 2018. According to the complaint, at each inspection, FDA documented significant deficiencies. For example, as alleged in the complaint, during the most recent inspection, FDA observed a failure to maintain the cleanliness of food contact sources, and a failure to ensure that all persons working in direct contact with food, food contact surfaces and food-packing materials conform to hygienic practices to protect against food contamination.

The complaint noted that, following the October 2014 inspection, the FDA issued a warning letter notifying Foo Yuan and Hsing Chuang that they were in violation of seafood Hazard Analysis and Critical Control Point and current Good Manufacturing Practice regulations, causing their products to be adulterated under the law.

The complaint alleged that defendants violated the Federal Food, Drug, and Cosmetic Act by causing adulterated food to be introduced into interstate commerce or delivered for introduction into interstate commerce. It also alleged that the defendants further violated the law by causing food to become adulterated while it was being held for sale after the shipment of one or more of its components in interstate commerce. The defendants did not file a response to the complaint.

“Taking steps to keep potentially unsafe food out of the U.S. food supply is at the heart of the FDA’s mission to protect public health,” said Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. “When a company does not follow good manufacturing practices and fails to come into compliance, the FDA will take action to protect the health and safety of Americans.”

The government is represented by the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Michael Castiglione of the U.S. Attorney’s Office for the Eastern District of New York, with assistance from Associate General Counsel for Enforcement Tara Boland of the Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.

Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of New York, visit its website at https://www.justice.gov/usao-edny.