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Blue Ocean Smokehouse of Half Moon Bay, Calif., has been ordered by the U.S. Food and Drug Administration to halt its seafood processing and distribution operations because of a risk of botulism and other food-safety hazards.

A complain filed by the U.S. Department of Justice in the U.S. District Court for the Northern District of California on 13 March alleges that the company is failing to comply with Hazard Analysis Critical Control Point (HACCP) requirements as well as Current Good Manufacturing Practice requirements, according to a statement released by the FDA on Thursday.

An FDA inspection in October 2011 found Listeria monocytogenes on both food and non-food surfaces in processing areas of the company’s facility. The agency added that Blue Ocean’s vacuum-packed hot and cold smoked fish products pose a risk for the development of the toxin that causes botulism.

However, no illnesses associated with Blue Ocean’s fish products have been reported to date.

Blue Ocean is operated by Fujino Enterprises; its president, Erika Fujino, is also named in the government’s complaint.

“This company has ignored warnings by the FDA and the California Department of Public Health by continuing to sell seafood that puts consumers’ health at risk,” said Dara Corrigan, the FDA’s 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.”


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