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FDA wants judge to shut down unsanitary Staten Island facility

Euroline Foods LLC and Royal Seafood Baza Inc. violated the Federal Food, Drug and Cosmetic Act by processing and distributing ready-to-eat fish, fishery products, vegetable salads and cheese products in a Staten Island facility where there were chronic unsanitary conditions.

So says a civil complaint filed Monday by the U.S. Department of Justice on behalf of the federal Food and Drug Administration.

The complaint alleges that FDA inspections 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, filed in U.S. District Court for the Eastern District of New York, also named as defendants the company’s owner/operators Eduard Shnayder, Syoma Shnayder and Albert Niyazov, and operator Oleg Polischouk.

“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. Also, the complaint alleges the defendants failed to comply with seafood Hazard Analysis and Critical Control Point (HACCP) regulations, which 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. FDA inspections in 2016 detected listeria contamination in several areas of the facility.

“Food processors and distributors must identify and eliminate food safety hazards and develop meaningful plans for preventing such hazards to protect consumers,” stated United States Attorney Richard P. Donoghue for the Eastern District of New York.

“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.”

The complaint seeks an order by the court to permanently enjoin the defendants from FDCA violations 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.

Trial Attorney James T. Nelson of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Gail A. Matthews of the U.S. Attorney’s Office for the Eastern District of New York, with the assistance of Associate General Counsel for Enforcement Jennifer C. Argabright of the FDA’s Office of the Chief Counsel are handling the matter for the government.

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