FDA pursues enforcement action against California fish processorFish may put consumers at risk of botulism and other food hazards
The U.S. Food and Drug Administration, in a complaint filed by the Department of Justice, is seeking to stop the processing and distribution of fish products at a California company because of a risk of botulism and other food hazards.
If granted, the permanent injunction against Fujino Enterprises Inc., doing business as Blue Ocean Smokehouse, of Half Moon Bay, Calif., would stop the company from processing and distributing fish and fish products. Blue Ocean's president Erika Fujino also is named in the government's complaint.
Blue Ocean processes fresh and smoked fish and fish products including salmon, cod, halibut, Wild King Salmon Candy (a honey-glazed, cold-smoked salmon), hot-smoked tuna, sturgeon and hot-smoked fish cream cheese spreads. Blue Ocean receives fish for processing from outside California, including salmon from Washington state and sturgeon from Oregon.
"This company has ignored warnings by FDA and the California Department of Public Health by continuing to sell seafood that puts consumers' health at risk," said Dara A. Corrigan, associate commissioner for regulatory affairs. "We are taking this action, in part, as a result of collaborative enforcement actions with our state partner and as part of our joint efforts to protect the public health."
The complaint alleges that the company's fish and fish products are adulterated, because they are processed under conditions that do not comply with the agency's Hazard Analysis Critical Control Point (HACCP) regulations. HACCP is a science-based system of preventive controls for food safety that is used by commercial seafood processors to identify potential food safety hazards and take steps to keep them from occurring.
The complaint also alleges that Blue Ocean's fish are adulterated because the conditions under which they are prepared, packed, and held fail to conform to the Current Good Manufacturing Practice requirements for food established to ensure that food is processed in a safe and sanitary manner. An FDA inspection in October 2011 found poor employee sanitation practices and showed that the company's facility was not maintained in a manner that protected against food contamination.