News & Events
FDA NEWS RELEASE
For Immediate Release: Sept. 27, 2010
Update: On September 22, 2010, in the Eastern District of Louisiana, Judge Mary Ann Vial Lemmon entered a consent decree of permanent injunction in this case. Sharkco Seafood International, Inc. and its owners, Khai Q. Nguyen and Tuan Q. Nguyen, are now prohibited from processing, preparing, packing, holding, and distributing scombrotoxin-forming fish unless and until, among other things, they have established an adequate Hazard Analysis and Critical Control Point (HACCP) plan for their scombrotoxin-forming fish. Sharkco and its owners may not resume operations related to scombrotoxin-forming fish until they receive permission from the FDA.
Media Inquiries: Ira Allen, 301-796-5349, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
For Immediate Release: November 24, 2009
Media Inquires: Siobhan DeLancey, email@example.com, 301-796-4668
Consumer Inquires: 1-888-INFO-FDA
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.
For more information on food safety, please visit www.foodsafety.gov.