DOJ files complaint for FDA against seafood processor with listeria issues

The United States filed a civil complaint against Long Island City, NY-based Foo Yuan Food Products Company Inc., its owner and president Hsing Chang, and its secretary Susan Chang, to stop them from preparing and distributing adulterated seafood products in violation of federal law.

The Department of Justice filed the complaint at the request of the U.S. Food and Drug Administration.

According to the federal complaint, defendants prepare, pack, hold and distribute refrigerated and frozen ready-to-eat fish balls, fried fish cakes and fried fish balls. The complaint, filed in the U.S. District Court for the Eastern District of New York, alleges that 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 ensuring that food processors comply with laws designed to ensure food safety,” said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The Department of Justice will continue to work with the FDA to ensure that Americans are protected from potentially unsafe food.”

When food processors ignore federal laws concerning the preparation of food, they subject the public to serious health risks, according to a statement from Richard P. Donoghue, U.S. Attorney for the Eastern District of New York. “The Department of Justice has asked the Court to stop the defendants from processing, packaging or distributing any more food until they establish that they can comply with federal laws and regulations designed to avert those health risks. Today’s action demonstrates our commitment to protecting the public from potentially contaminated food,” Donoghue said.

The 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 people working in direct contact with food, food contact surfaces, and food-packing materials conform to hygienic practices to protect against food contamination.

The complaint notes that, following the October 2014 inspection, FDA issued a warning letter notifying Foo Yuan and Hsing Chang 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 federal law.

The complaint alleges 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 alleges 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 government is represented by Trial Attorney Monica Groat of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Edwin Cortes of the U.S. Attorney’s Office for the Eastern District of New York, with the assistance of Associate Chief Counsel for Enforcement Tara Boland of the FDA, Office of General Counsel, Department of Health and Human Services.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.

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