A fish smoking company based in Mamaroneck, New York, U.S.A., has been ordered to cease sales of its products by a federal judge after the U.S. Food and Drug Administration (FDA) found its processing facility contaminated with the bacteria that causes listeriosis.
The Smokehouse of New York, LLC, its president and owner, Panagiota Soublis, and Brett H. Portier, its director of operations, were issued a consent decree of permanent injunction by Joon H. Kim, the U.S. Attorney for the Southern District of New York on Thursday, 29 June. An FDA press release said that L. mono, a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness, had been found in repeated visits to the business’ processing facility.
“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 FDA initially reported finding the bacteria in a sample of the company’s cold-smoked salmon being stored in the Mamaroneck facility in August 2011. The warning letter issued by the FDA in 2011 also outlined Smokehouse’s violations of the seafood Hazard Analysis Critical Control Point (HACCP) regulations and the Current Good Manufacturing Practice regulations for food.
Additional inspections in 2013 and 2015 found L. mono in the Smokehouse processing facility, the FDA said. Smokehouse agreed to address the FDA’s concerns, but subsequent inspections revealed the business’ corrective plan was 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,” according to the FDA's press release.
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.
In a the consent decree, Soublis and Portier agreed not to prepare, process, manufacture, pack hold FDA-regulated food products until they demonstrate that their facility processing equipment and sanitation controls are suitable to prevent L. mono. They also must 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, according to the consent decree.
To date, no illnesses have been reported from The Smokehouse of New York, LLC’s products. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis.