The US Department of Justice stated it had filed a lawsuit and was seeking a preliminary injunction against N.Y. Fish Inc., New York City Fish Inc. and key employees.
The action is being taken under the federal Food, Drug and Cosmetic Act on behalf of the US Food and Drug Administration (FDA). Although NY Fish had ceased manufacturing, the FDA believes its products continue to be distributed and sold from the Chester Street site in Brooklyn.
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 law.
‘Life-threatening bacteria’
“Inspectors who visited the defendants’ facilities found … life-threatening bacteria,” said Loretta Lynch, US attorney for the Eastern District of New York in a statement issued last Friday.
“Despite repeated warnings and direction to sanitise the facility, the defendants have failed to do so. They cannot be allowed to distribute potentially unsafe food to our families.”
Melinda Plaisier, FDA acting associate commissioner for regulatory affairs, said: “These companies have ignored previous warnings by the FDA and have continued to produce and distribute products in violation of federal law.
“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 FDA’s complaint, it conducted seven inspections of the Brooklyn factory from 2006-2013.
Listeriosis and botulism
The inspections showed a repeated failure to minimise the risk of contamination from listeria monocytogenes, from which consumers can contract listeriosis and clostridium botulinum, from which consumers can contract botulism. Both diseases can prove fatal.
The FDA’s most recent inspection occurred in February 2013, when New York City Fish was operating the processing facility.
According to court filings, the company missed critical processing steps that are essential to prevent the growth and toxin production of clostridium botulinum and to eliminate any listeria monocytogenes contamination. These included heating fish for a dangerously short time and using insufficiently salty brining solution.
Widespread sanitation problems
The FDA previously investigated the facility in August 2012, when it was operated by N.Y. Fish. FDA inspectors discovered widespread sanitation problems and a similar failure to meet critical steps necessary to prevent contamination.
They also found salmon products and production equipment contaminated with listeria monocytogenes, even after the company attempted to clean and sanitize the facility.
Further testing by the FDA revealed that certain strains of listeria monocytogenes it found likely had persisted in the Chester Street facility for years.
The FDA contends that the facility is so infiltrated with listeria monocytogenes that New York City Fish must institute heightened monitoring and strict sanitation procedures to have any hope of eradicating this life-threatening organism, but that it has failed to do so.
The lawsuit is being brought by assistant US attorney Elliot Schachner of the Eastern District of New York, and trial attorney Adrienne Fowler of the Civil Division’s Consumer Protection Branch, with the assistance of associate chief counsel for enforcement Julie Dohm of the FDA.