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April 20, 2007 — /FDA News/ — The U.S. Food and Drug Administration (FDA) today announced that Worldwide Fish & Seafood, Inc., Minneapolis, MN, (doing business as Coastal Seafood) a seafood processor and three of its officers have entered into a consent decree of permanent injunction due to violations of the Federal Food, Drug and Cosmetic Act.
The consent decree requires the company to come into compliance with the act by developing and implementing adequate Hazard Analysis and Critical Control Point (HACCP) plans.
The seafood HACCP regulations require that all seafood processors develop and implement adequate HACCP plans that identify all food safety hazards that are likely to occur for each kind of seafood product, and contain preventative measures that the processor can implement to control those hazards.
Over six years, seven FDA inspections revealed that the defendants’ HACCP plans were not adequate to prevent conditions that could pose a potential public health risk. In particular, the defendants’ HACCP violations related to their failure to ensure that their seafood products were transported and continuously stored at adequate refrigeration temperatures to prevent bacteria growth and pathogen development.
The defendants agreed to come into compliance with the act and its implementing regulations by, among other requirements: obtaining an expert consultant to evaluate the HACCP plans for all of the defendants’ products and the defendants’ implementation of the plans; and submitting to FDA inspection to ensure that the HACCP plans are being adequately implemented.
The defendants have already received FDA approval of the HACCP plans prepared by their expert and currently in use.
The decree allows FDA to order a shutdown, recall, or other corrective action in the event of future violations, and requires the defendants to pay the costs of inspections performed pursuant to the decree. The decree was entered by Judge Joan Erickson of the U.S. District Court for the District of Minnesota on April 18, 2007.