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UPDATE: On March 30, 2014, Judge Roslynn R. Mauskopf of the Eastern District of New York ordered a permanent injunction against New York City Fish, Inc. in Brooklyn, N.Y., and the company’s senior leadership. New York City Fish, Inc. prepares, processes, packs, holds and distributes ready-to-eat smoked and cured fishery products, including salmon, mackerel and herring. The order, which requires the company to cease production and distribution until it can demonstrate compliance with the Food Drug & Cosmetic Act (FD&C Act), comes after the United States filed a complaint against the defendants in May 2013 for introducing adulterated food into interstate commerce. During inspections of the facility since 2006, U.S. Food and Drug Administration investigators have found numerous violations of the FD&C Act, as well as the presence of Listeria monocytogenes (L. mono) throughout the facility and in finished fishery products. L. mono can cause a serious illness called listeriosis, which can be fatal, especially in certain high-risk groups.
FDA NEWS RELEASE
For Immediate Release: May 17, 2013
Media Inquiries: Tamara Ward, 301-796-7567, email@example.com
Consumer Inquiries: 888-INFO-FDA
FDA seeks preliminary injunction against New York fish manufacturer
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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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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