SILVER SPRING, Md., June 30, 2017 (PRNewswire-USNewswire) — A New York smoked fish company has been ordered by a federal court to stop selling its products, which were produced in a facility that was contaminated with Listeria monocytogenes (L. mono), until it can comply with food safety regulations.
On June 29, 2017, the U.S. District Court for the Southern District of New York entered a consent decree of permanent injunction between the United States and The Smokehouse of NY, LLC, located in Mamaroneck, New York (Smokehouse), its director of operations Brett Portier, and its president and owner Panagiota Soublis. The complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, sought a permanent injunction against the defendants so that they cannot prepare, process, manufacture, pack and/or hold FDA-regulated food products until they demonstrate that their facility processing equipment and sanitation controls are suitable to prevent L. mono.
L. mono is a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis.
"The Smokehouse of NY had several opportunities to come into compliance with the law," FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said. "Through the use of modern technology, the FDA was able to establish that the company has resident strains of L. mono in its facility that it has consistently failed to eradicate. Conditions like these are unacceptable and the FDA took action to protect Americans."
The complaint outlines a long history of recurring food safety violations. In August 2011, the FDA issued a Warning Letter related to findings of L. mono in the Smokehouse processing facility and in a sample of the company's cold-smoked salmon. The Warning Letter also outlined Smokehouse's violations of the seafood Hazard Analysis Critical Control Point regulations and the Current Good Manufacturing Practice regulations for food.
Additional inspections in 2013 and 2015 found L. mono in the Smokehouse processing facility. Smokehouse agreed to address and correct the inadequate conditions through specific action plans. However, subsequent inspections by the FDA found that these plans were not consistently implemented. During the FDA's most recent inspection in April 2017, investigators found widespread L. mono in the facility, including on direct food contact surfaces. The FDA also observed poor sanitation practices including inadequate employee handwashing, improper disinfection practices and a failure to prevent cross-contamination between raw, in-process and finished products.
Following the 2017 inspection, the FDA used a technique called whole genome sequencing to identify persistent strains of L. mono at the Smokehouse facility. Whole genome sequencing technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source or a person who became ill from consuming contaminated food.
According to the consent decree, the defendants must, among other things, retain an independent laboratory to collect and analyze samples for the presence of L. mono, retain an independent expert and develop a program to control L. mono, and eliminate insanitary conditions at the facility if they wish to resume operations. Should the defendants be permitted to resume operations in the future, the FDA maintains oversight over such operations under the consent decree and may order the defendants to take corrective actions if the agency discovers further food safety violations.
To date, no illnesses have been reported from The Smokehouse of New York, LLC's products. Individuals who have eaten products purchased from the company should contact a health care professional if they experience any symptoms of listeriosis. In addition, consumers are encouraged to contact the FDA to report problems with FDA-regulated products.
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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.