Until it can safely produce food as required under the Federal Food, Drug, and Cosmetic Act, Neptune Manufacturing Inc. in Los Angeles has been ordered to stop processing and distributing its smoked and pickled seafood products.
According to a Dec. 4 news release from the U.S. Food and Drug Administration (FDA), U.S. District Court Judge S. James Otero signed a consent decree of permanent injunction Dec. 1 against Neptune and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.
The decree orders the company and its owners to stop processing and distributing smoked and pickled seafood products until they have taken specific steps to bring their operation into compliance with federal law.
Neptune prepares, processes, packs, holds and distributes ready-to-eat smoked and salt-cured (pickled) fish and fishery products, including pickled herring, smoked steelhead trout, smoked turbot/halibut, smoked whitefish, smoked salmon and smoked mackerel. The company sells its ready-to-eat products wholesale to customers located in southern California and Las Vegas.
FDA stated that its inspectors had made seven visits to the company’s LA facility since 2006, and, each time they found similar unsanitary conditions. (The language in the law refers to unsanitary conditions as “insanitary.”) FDA investigators found Listeria monocytogenes at the facility on four occasions and failure to control for Clostridium botulinum growth and toxin formation on at least three occasions, the agency stated.
Listeria is a foodborne pathogen that can cause serious illness or even death in vulnerable groups such as newborns, elderly adults and those with impaired immune systems. Clostridium bacterium can grow in seafood products and causes botulism, which is rare but can cause paralysis and death without prompt treatment.
“When a company and its owners repeatedly violate the same food safety procedures, their failure to improve their processes and clean up their facility endangers the public,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA will take necessary action to protect the food supply from adulteration.”
No illnesses have been reported to date associated with Neptune Manufacturing products, FDA stated. The agency added that consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.
Among other requirements, the decree states that Neptune may not continue to receive, prepare, process, pack, label, hold or distribute food items until the company retains an independent lab qualified to test for the presence of Listeria in product and environmental samples, conducts hazard analyses to develop adequate HACCP plans, develops adequate plans to control Clostridium for all fish and fishery products, and ensures that all fish five inches long or more are eviscerated before being salted or submerged in a salt solution.
All the stated requirements must meet with FDA approval and be monitored by the agency for compliance, according to the decree. It also orders fines for each day that any violations of the law continue.