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FDA Seeks Permanent Injunction Against Sharkco Seafood International Inc.


Sharkco’s History of Violations Prompts FDA to Seek Court Action

The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigeratedcan result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.

The government’s complaint, filed today by the United States Attorney’s Office for the Eastern District of Louisiana charges Sharkco Seafood and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, with violating the Federal Food, Drug, and Cosmetic Act by failing to establish and implement an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. FDA requires all seafood processors and distributors to have a HACCP plan that determines and monitors food safety hazards associated with their products.

“FDA repeatedly warned and tried to work with Sharkco Seafood,” said Michael Chappell, acting associate commissioner for regulatory affairs at FDA. “The company had ample time to take correction action, which it failed to do. An effective seafood HACCP plan is critical to safeguard the health of the American people. We will take prompt action against companies whose poor business practices could jeopardize the public health.”

According to the government’s complaint, FDA inspections showed that the defendants failed to have an adequate written HACCP plan for their scombrotoxin-forming fish operation, despite numerous warnings by FDA. The formation of scombrotoxin can be adequately controlled when fish are appropriately preserved or refrigerated. Once formed, however, scombrotoxin cannot be removed or destroyed by washing, freezing, or cooking the affected fish.

No illnesses have been associated with Sharkco Seafood’s scombrotoxin-forming fish products. The company produces other seafood products, which are not affected by this action.

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