The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the Eastern District of New York against New York City Fish, Inc., and several key employees for manufacturing and distributing ready-to-eat fish products under insanitary conditions causing them to become adulterated.
The defendants process smoked and cured fish products, including salmon and mackerel, and sell their food to stores in Maryland, Massachusetts, Pennsylvania, and New Jersey. The injunction is intended to restrain the parties from distributing these products into interstate commerce until they comply with the requirements of the Federal Food Drug and Cosmetic Act (Act).
“These companies have ignored previous warnings by the FDA and have continued to produce and distribute products in violation of federal law,” said Melinda Plaisier, the FDA’s acting associate commissioner for regulatory affairs. “This lawsuit shows that the FDA will aim to protect public health by seeking enforcement action against companies that are identified as violating federal requirements.”
According to the government’s complaint, the FDA has conducted a total of seven inspections between 2006-2013, and, during six of these inspections, inspectors collected samples that were later revealed to have Listeria monocytogenes (”L. mono”). L. mono is the bacterium that causes the disease Listeriosis, which can be serious, even fatal, for vulnerable groups such as unborn babies, newborns, and those with impaired immune systems. Inspectors also found they repeatedly failed to: have and implement a Hazard Analysis Critical Control Point (HACCP) plan for their seafood products; verify required records in a timely manner; and implement required corrective actions. All manufacturers of seafood products must have and implement a HACCP plan for each of its locations that address each process and kind of product processed at the facility and associated food safety hazards that are reasonably likely to occur.
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