The U.S. District Court for the Central District of California entered a consent decree of permanent injunction on Dec. 1 against Neptune Manufacturing Inc. of Los Angeles and its corporate officers, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky, to prevent the distribution of adulterated seafood products, the Department of Justice announced today.
The department filed a complaint in the U.S. District Court for the Central District of California on Nov. 21 at the request of the U.S. Food and Drug Administration (FDA), alleging the company’s seafood products are produced under conditions that are inadequate to ensure the safety of its products. The complaint alleges that Neptune prepares, processes, packs, holds and distributes ready-to-eat smoked and salt-cured seafood including pickled herring, smoked steelhead trout, smoked halibut, smoked whitefish, smoked salmon and smoked mackerel. The complaint also alleges that defendants Goldring, Oyrekh and Krutovsky are Neptune’s corporate officers with the authority and responsibility for preventing and correcting violations of federal law at the company.
In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the federal Food, Drug, and Cosmetic Act. The consent decree requires Neptune to cease all manufacturing operations and requires that, in order for defendants to resume distributing seafood products, the FDA first must determine that Neptune’s manufacturing practices have come into compliance with the law.
“Neptune was repeatedly informed that the sanitation practices at its facility were deficient,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division. “The failure to actively plan for and control the presence of bacteria and neurotoxins commonly found in seafood processing facilities can pose a serious risk to the public health.”
According to the complaint, since 2006, FDA inspections have documented a pattern of continuing conduct of insanitary conditions resulting in the persistent presence of Listeria monocytogenes (L. mono). These insanitary conditions were the result of deviations from current good manufacturing practices such as not adequately cleaning surfaces and utensils used for cutting fish. Further, according to the complaint, the FDA’s most recent inspection in December 2013 documented the defendants’ failure to have and comply with adequate Hazard Analysis and Critical Control Point (HACCP) plans that control for Clostridium botulinum (C. bot) and L. mono hazards. L. mono is the bacterium that causes listeriosis, a serious and sometimes fatal infection for vulnerable groups such as newborns, the elderly and those with an impaired immune system. Ingestion of the neurotoxin C. bot can cause botulism. Though the incidence of botulism is rare, its effect is severe and the disease can cause paralysis or death if not promptly treated.
According to the complaint, the FDA has performed seven inspections of the defendants’ facility since 2006 and documented seafood HACCP or current good manufacturing practice violations every time. The complaint alleges that these inspections revealed that the company’s products are adulterated within the meaning of the Food, Drug, and Cosmetic Act. As alleged in the complaint, the company was told to take certain precautions while brining fish to control potential C. bot hazards but failed to take appropriate corrective action. Further, according to the complaint, cutting utensils were seen with dried pieces of fish on them, and exposed cracks, pits and crevices on the floor allowed water to pool in them, increasing the risk of L. mono contamination. The complaint alleges that FDA environmental samples taken around the facility tested positive for L. mono in critical areas such as the brining room, smoking/drying room and the walk-in cooler where finished products are stored.
The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch, with the assistance of Assistant U.S. Attorney Deborah Yim for the Central District of California and Assistant Chief Counsel for Enforcement Yen Hoang of the U.S. Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.