U.S. files complaint against New York food distributors
In a complaint, at the request of the U.S. Food and Drug Administration (FDA), the United States alleged 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.
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.
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, 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, 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. ■