If granted, the US Department of Justice (USDOJ)-filed injunction would permit the FDA to permanently prevent Fujino Enterprises Inc., which operates under the name Blue Ocean Smokehouse, processing and distributing its fresh and smoked fish and fish products.
The complaint alleges that processing and distributing practices do not comply with seafood Hazard Analysis Critical Control Point (HACCP) regulations or Current Good Manufacturing Practice requirements for food.
The company’s president Erika Fujino is also named in the complaint, which was filed with the US District Court for the Northern District of California.
Despite the FDA’s intentions, to-date no illnesses have actually been linked to Blue Ocean products.
The proposed injunction follows a November 2010 FDA warning letter to the company which noted “serious violations.”
According to an FDA statement on the matter, an October 2011 inspection found that the company’s facility was not maintained “in a manner that protected against food contamination.”
“Blue Ocean’s vacuum-packaged hot and cold smoked fish products may pose a risk for the development of Clostridium botulinum toxin that can cause botulism, a rare but serious illness that may result in paralysis, inhibited respiration, and death.”
“Investigators also found Listeria monocytogenes (L. mono) on food-contact and non-food-contact surfaces in the food processing areas of the company’s facility."
“In addition, Blue Ocean’s tuna products may pose a risk for the development of scombrotoxin (histamine), a toxin that also cannot be removed by cooking or freezing, and that can cause an illness known as scombrotoxin poisoning.”
According to the FDA statement, these violations led to the FDA and California Department of Public Health-supervised voluntary destruction of almost 1,500 pounds of smoked fish in October 2011.
FDA associate commissioner for regulatory affairs Dara A. Corrigan said: “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.”
A warning letter from the FDA to Blue Ocean dated 19 November 2010 vowed “further action” if efforts were not made at the facility.
The letter, which followed an inspection at the facility, cited several seafood HACCP and Current Good Manufacturing Practice violations.
“Accordingly, your refrigerated, vacuum packaged, ready-to-eat hot smoked and cold smoked salmon is adulterated, in that it has been prepared, packed, or held under insanitary conditions, whereby it may have been rendered injurious to health,” said the warning letter.
“We may take further action if you do not promptly correct these violations,” it added.