FDA: Neptune Manufacturing Must Take Steps to Safely Produce Seafood

California seafood company to halt production until FDA documents correction of unsanitary practices

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

On December 1, a federal judge from the U.S. District Court for the Central District of California entered a consent decree of permanent injunction against Neptune Manufacturing, Inc., of Los Angeles, and its owners, Alexander Goldring, Peter Oyrekh and Semyon Krutovsky.

The consent decree requires Neptune and its owners to stop processing and distributing their smoked and pickled seafood products until they have taken specific steps to bring their operation into compliance with the Federal Food, Drug, and Cosmetic Act (“the Act”).

Neptune Manufacturing 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.

The FDA has conducted seven inspections of the facility since 2006. Each time, FDA investigators found similar unsanitary conditions. (The Act refers to unsanitary conditions as insanitary.) FDA investigators found the pathogenic bacterium Listeria monocytogenes (L. mono) on four occasions at the facility. FDA investigators also found a failure to control for Clostridium botulinum (C. bot) growth and toxin formation on at least three occasions.

L. mono 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. C. bot, a bacterium that can grow in seafood products, causes botulism, which is rare but can cause paralysis and death without prompt treatment. The purpose of food safety regulations is, in part, to prevent the growth and spread of L. mono, C. bot and other microorganisms that cause foodborne illness.

“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, Inc. products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

For more information:

Please view the three spreadsheets summarizing findings of the Neptune Manufacturing, Inc. inspections.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Review Date: 
December 4, 2014