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FDA files injunction against fish products manufacturer

May 21, 2013
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Savory fish on grill
The FDA collected evidence that a New York-based ompany's fish products are not safe for consumers and shouldn't be distributed.

The U.S. Department of Justice has demanded a preliminary injunction on behalf of the U.S. Food and Drug Administration (FDA) against New York City Fish, Inc., over concerns that its products do not meet federal standards of safety and could pose a threat to public health.

The FDA has collected evidence that the New York-based company's ready-to-eat fish products, including smoked salmon and mackerel, are not safe for end-consumers and should not be distributed on the market, the agency explained. The suit filed against the company claimed that it had "a history of processing fishery products under insanitary conditions, with inadequate safety procedures."

The company, which sells its products to retailers in several states, including Maryland, Massachusetts, Pennsylvania and New Jersey, has been accused of manufacturing products under insanitary conditions at its facility. The FDA stated that the products were "adulterated" under the Federal Food, Drug and Cosmetic Act.

The DOJ has requested a preliminary injunction against the Brooklyn, N.Y.-based company and several key employees that have allegedly failed to ensure that the facility met safety standards, including Maxim Kutsyk, Pavel Roytkov, Leonid Staroseletesky and Steven Koyfman. Manufacturing operations at the plant have been terminated but FDA officials believe that products are still being distributed and sold, which is the reason behind asking for a preliminary injunction.

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According to Melinda Plaisier, the FDA's acting associate commissioner for regulatory affairs, New York City Fish, Inc. has repeatedly ignored warnings issued by the FDA and has continued to manufacture and distribute its products in violation of federal laws. The lawsuit filed against the company is evidence that the FDA is committed to protect public health by taking steps against companies that fail to comply with federal requirements, Plaisier stated.

The agency revealed that FDA inspectors had conducted seven inspections between 2006 and 2013. During six of them, inspectors collected samples that were later found to be contaminated with bacteria, known as Listeria monocytogenes. The bacterium causes the serious and potentially fatal disease Listeriosis, which is particularly dangerous to vulnerable groups such as unborn babies, newborns and people with weakened immune systems. Clostridium botulinum, another dangerous bacterium, was reportedly discovered at the facility as well.

Inspectors also found that the company had repeatedly failed to implement a Hazard Analysis Critical Control Point (HACCP) plan for its products and did not verify required records within the time frames provided by inspectors. Although corrective measures were ordered, New York City Fish, Inc. failed to implement them. Under current regulations, all manufacturers of seafood products must have and implement a HACCP plan for each of their facilities, addressing each process and type of product processed there.

If accepted, the injunction will keep the fish processor from distributing its products until it complies with the requirements of the Federal Food, Drug and Cosmetic Act.

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