The United States has filed a civil complaint in federal court in Brooklyn seeking to permanently enjoin two companies that own and operate a Staten Island facility from manufacturing and distributing adulterated food, the Department of Justice announced today.
According to the complaint filed at the request of the U.S. Food and Drug Administration (FDA), the United States alleges that Euroline Foods, LLC, and Royal Seafood Baza, Inc., violated the Federal Food, Drug and Cosmetic Act (FDCA) by processing and distributing ready-to-eat fish and fishery products, vegetable salads, and cheese products in a facility with chronic insanitary conditions. Inspectors from the FDA found Listeria monocytogenes (L. mono) at the companies’ facility, and that the defendants failed to put in place adequate measures to reduce the risk of health hazards such as L. mono, Clostridium botulinum, and scombrotoxin. The complaint also named as defendants the companies’ owner/operators Eduard Shnayder, Syoma Shnayder and Albert Niyazov, and operator Oleg Polischouk.
“Food processors and distributors must identify and eliminate food safety hazards and develop meaningful plans for preventing such hazards in order to protect consumers," stated United States Attorney Donoghue. “Those who fail to do so must come into compliance or be shut down. We have, and will continue, to use all means at our disposal to protect the public from the dangers of harmful pathogenic bacteria, including bacteria that cause listeriosis and other serious illnesses."
“L. mono presents a significant danger to public health and can prove fatal to vulnerable individuals," said Acting Assistant Attorney General Chad A. Readler of the Justice Department’s Civil Division. “The food consumers purchase must be safe to eat, and we will continue to work with FDA to take action against companies that refuse to improve dangerously substandard practices."
According to the complaint, the defendants failed to adequately implement effective sanitation controls that complied with current Good Manufacturing Practices (cGMP) requirements. In addition, the complaint alleges that the defendants failed to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations that are designed to mitigate food safety hazards associated with the processing of fish and fishery products.
Three FDA inspections of the defendants’ facility in March 2015, February to March 2016, and November to December 2016, as well as a follow-up investigation in November 2017, all uncovered cGMP and HACCP violations. The FDA issued a Warning Letter to Royal Seafood in 2015, and FDA inspections in 2016 detected listeria contamination in several areas of the facility.
The complaint seeks an order by the Court to permanently enjoin the defendants from violating the FDCA and to prevent them from manufacturing or distributing food unless they comply with specific remedial measures including developing and executing an effective sanitation program.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.
This matter is being handled by Assistant U.S. Attorney Gail A. Matthews of the United States Attorney’s Office for the Eastern District of New York, Trial Attorney James T. Nelson of the Civil Division’s Consumer Protection Branch, with the assistance of Associate General Counsel for Enforcement Jennifer C. Argabright of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Eastern District of New York, visit its website at https://www.justice.gov/usao-edny.
Source: U.S. Department of Justice, Office of the United States Attorneys
