News & Events
FDA NEWS RELEASE
For Immediate Release: Nov. 13, 2009
Update: On March 2, 2010, in the Eastern District of New York, Judge Dora L. Irizarry entered a consent decree of permanent injunction in this case. Haifa Smoked Fish, Inc., along with two of its executives, Arcadi Marcovich and Israel Mirzakandov, are now prohibited from manufacturing, distributing and selling the firm’s products unless and until they have taken measures approved by the FDA to correct insanitary conditions and control the pathogenic bacterium Listeria monocytogenes (L. mono.) at the facility. The firm may not resume operations until it receives permission from the FDA.
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FDA Takes Action against Seafood Processing Company, Executives
Failure to correct repeated federal violations prompts agency action
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.
If the court grants the injunction requested by the government, the company would stop the manufacture, distribution, and sale of its products, unless and until it has implemented measures to correct insanitary conditions and control the pathogenic bacterium Listeria monocytogenes (L. mono.) at the Haifa Smoked Fish facility. The act refers to unsanitary conditions as insanitary.
“This company has consistently failed to make corrections to improve the insanitary conditions under which it processes smoked fish products, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate food companies that fail to provide adequate safeguards to protect the public.”
The company processes and distributes brined, cold-smoked, and hot-smoked fish and fishery products. The violations documented by the FDA pose a public health hazard because, without adequate controls, products made by Haifa Smoked Fish could become contaminated with (L. mono) or other pathogens and could cause serious illnesses.
“The public must be able to trust that the food in their grocery stores is safe for them to eat,” said Benton J. Campbell, the United States Attorney for the Eastern District of New York. “We will continue to work with the FDA to ensure that companies that produce food under dangerous or insanitary conditions take corrective action to clean up their act.”
Since 2001, the FDA and the New York State Department of Agriculture and Markets (NYSDAM) have inspected the Haifa Smoked Fish facility on numerous occasions. The inspections revealed insanitary conditions that could lead to the contamination of the finished product with L. monoor other pathogenic microorganisms. The act refers to unsanitary conditions as insanitary.
FDA analyses of samples taken during the inspections revealed that food products and environmental surfaces, including food-contact surfaces, were contaminated with L. mono. The defendants also continually failed to comply with FDA’s Hazard Analysis and Critical Control Point (HACCP) regulations. HAACP regulations require that seafood processors identify all food safety hazards likely to occur for each kind of seafood product, and develop and implement adequate plans to prevent and control those hazards.
The FDA issued warning letters to Haifa Smoked Fish in 2001 and 2004. In response, company officers promised to correct the violations. Subsequent inspections, however, revealed that the company did not make the corrections.
The complaint was filed in the U.S. District Court for the Eastern District of New York.