New York - Two New York-based food processing companies have agreed to stop preparing food products, which include a variety of ready-to-eat foods and certain salt-cured and pickled fish, because the facility’s food preparation areas were contaminated with Listeria monocytogenes (L. mono), until the companies can comply with federal food safety laws and regulations.

On July 16, 2018, U.S. District Judge Brian M. Cogan for the Eastern District of New York entered a consent decree of permanent injunction between the U.S. 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 jointly own a food processing facility, and the consent decree prohibits the defendants from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at this facility, or any other facility that receives, prepares, processes, packs, labels, holds and/or distributes food that presents a L. mono hazard, in 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, and is in compliance with the FD&C Act, or from operating retail food establishments (i.e., grocery stores).

“FDA investigators found widespread L. mono contamination at the Euroline and Royal Seafood facility,” FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier said. “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 the complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, the FDA inspected the defendants’ facility in 2015, 2016 and 2017. These inspections revealed that the defendants failed to comply with the FD&C Act and its implementing 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 the 2016 inspections, the FDA’s investigators conducted environmental sampling and found L. mono from the seafood and vegetable processing environments, as well as continuing inadequate sanitation practices by the company’s employees. 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. While the company subsequently conducted a voluntary, nationwide recall of its ready-to-eat herring products for L. mono concerns and defendants made assurances that they were correcting its violations, the FDA’s subsequent inspections revealed that the company had not implemented adequate corrective actions.

The consent decree requires defendants, among other things, to retain an independent laboratory to collect and analyze environmental and finished food samples for the presence of L. mono, retain a qualified independent expert to assist the company in developing a program to control L. mono 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 L. monohazard.

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 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.

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.