Deputy Assistant Attorney General Arun G. Rao Delivers Remarks at the Jefferson Literary and Debating Society’s Distinguished Speaker Series
After a bench trial handled by the Department of Justice, the U.S. District Court for the Eastern District of New York has entered an injunction against New York City Fish Inc., Maxim Kutsyk, Pavel Roytkov and Leonid Staroseletesky under the federal Food, Drug and Cosmetic Act (FDCA). The court found that each of the defendants had violated the FDCA in the past and that the court had “scant assurance” that defendants would comply with food safety laws going forward. The defendants manufacture ready-to-eat fishery products, including smoked salmon and mackerel, and operate out of a food processing facility located at 738 Chester Street in Brooklyn.
In its verdict, the court found that each of the defendants had failed to keep the Chester Street Facility in compliance with current Good Manufacturing Practices, failed to keep records necessary to evaluate food safety and processed fish in a way that could lead to Listeria monocytogenes (L. mono) contamination. People who eat food contaminated with this bacterium can contract the disease listeriosis, which can be serious—even fatal—for vulnerable groups such as newborns and those with impaired immune systems. Complications from the disease can also lead to miscarriage. The court also found that, during several inspections dating back to 2006, FDA testing revealed the presence of L. mono in the facility.
The court ordered injunction provides for important remedies. Among other provisions, the injunction prohibits defendants from operating the Chester Street Facility until an independent laboratory and an independent sanitation expert develop a Listeria Monitoring Program satisfactory to the FDA and until the FDA is satisfied that defendants will fully comply with that program on an ongoing basis. The facility cannot begin operating again until defendants have cleaned and sanitized the Chester Street Facility and laboratory testing shows that L. mono is no longer present in the facility.
The lawsuit was handled by Trial Attorney Adrienne Fowler of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Elliot M. Schachner of the Eastern District of New York, with the assistance from FDA Assistant Chief Counsel for Enforcement Julie Dohm.