Operators of two New York food processing companies agreed to stop preparing foods until they can comply with federal food safety laws and regulations. The action comes after Listeria monocytogenes was found in food preparation areas of their jointly owned processing facility.
The companies process a variety of foods, including a variety of ready-to-eat foods and certain salt-cured and pickled fish, according to a notice from the Food and Drug Administration.
On Monday, U.S. District Judge Brian M. Cogan for the Eastern District of New York entered a consent decree of permanent injunction between the federal government and Euroline Foods LLC; Royal Seafood Baza Inc.; the companies’ co-owners Eduard Shnayder, Syoma Shnayder and Albert Niyazov; and a manager, Oleg Polischouk.
Euroline Foods LLC and Royal Seafood Baza Inc. jointly own a food processing facility in Staten Island, NY. The consent decree prohibits the defendants from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at the facility, or any other facility that receives, prepares, processes, packs, labels, holds and/or distributes food that presents a Listeria monocytogenes hazard, which is a violation of the federal Food, Drug, and Cosmetic Act (FD&C Act) until the defendants meet certain requirements.
The consent decree does not, however, prevent defendants from receiving, holding and distributing food that remains completely sealed and enclosed by a container, as long as it is in compliance with the FD&C Act, or from operating retail food establishments such as grocery stores.
“FDA investigators found widespread L. mono (Listeria monocytogenes) contamination at the Euroline and Royal Seafood facility,” FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaister said in the agency’s notice. “With this agreement, the company will not be able to bring any contaminated products or potentially contaminated products to market. Conditions, where their products were being produced, were unacceptable, and the FDA took action to protect Americans.”
According to a complaint filed by the U.S. Department of Justice on behalf of FDA, the agency inspected the defendants’ facility in 2015, 2016 and 2017. The inspections revealed that the defendants failed to comply with the FD&C Act and its regulations, including the seafood Hazard Analysis and Critical Control Point (“HACCP”) regulations and Current Good Manufacturing Practice (“CGMP”) regulations.
In 2015, the FDA issued a warning letter to Royal Seafood Baza after a facility inspection identified violations of HACCP and CGMP regulation requirements.
During 2016 inspections, the FDA’s investigators conducted environmental sampling and found Listeria monocytogenes in the seafood and vegetable processing environments, as well as ongoing inadequate sanitation practices by employees.
Listeria monocytogenes 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.
While the company subsequently conducted a voluntary, nationwide recall of its ready-to-eat herring products because of Listeria monocytogenes concerns. At that time company officials made assurances that they were correcting violations. the FDA’s subsequent inspections revealed that adequate corrective actions had not been implemented.
The consent decree requires defendants to, among other things, retain an independent laboratory to collect and analyze environmental and finished food samples for the presence of Listeria monocytogenes; retain a qualified independent expert to assist the company in developing a program to control the pathogen and ensure compliance with CGMP requirements; and take other corrective actions if they wish to resume food preparation operations at the facility or any other facility that receives, prepares, processes, packs, labels, holds and/or distributes food that presents a Listeria monocytogenes hazard.
Should the defendants be permitted to resume or permit food preparation operations at its current facility 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.
Individuals who have eaten products purchased from the companies should contact a healthcare professional if they experience any symptoms of listeriosis. In addition, consumers are encouraged to contact the FDA to report problems with any FDA-regulated products.
