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FDA’s Final Warning Letter of 2015 Targets Seafood Processing Facility

Food safety has become a major issue and subject of public concern recently, with widespread foodborne illness outbreaks hitting the headlines on a regular basis. In its final warning letter of 2015, the U.S. Food and Drug Administration (“FDA”) has issued a warning to Edo Sushi Express, a seafood processing company, claiming that it found “serious violations” of the Hazard Analysis and Critical Control Point (“HACCP”) standards applicable to seafood.

HACCP is a system designed to ensure food safety is addressed throughout the food production chain. It requires the analysis and control of certain physical, chemical, and biological hazards associated with turning raw materials into final products intended for human consumption. When it comes to seafood, pathogens and parasites present particular risks.

During September 2015, the FDA issued multiple warning letters to the company, identifying a number of deficiencies. For example, the letters specified that products from the facility were prepared or packaged in unsanitary conditions that pose risks to consumers. Although the company responded to the September 2015 warning letters, it omitted any documentation supporting its contention that it made the required modifications.

According to the most recent warning letter, seafood products produced at the facility, including ready-to-eat sushi, are “adulterated in that they have been prepared, packaged, or held under unsanitary conditions whereby they may have been rendered injurious to health.” Additionally, at least four of the company’s products were deemed adulterated due to the presence of an unsafe food additive known as phenylalanine. Two of the four products were also deemed misbranded because they failed to list eggs as one of the ingredients, which is a major allergen that can cause severe illness and even death if consumed by egg allergy sufferers.

A number of other labeling deficiencies were also identified in the letter, including concerns over how the company defines “fish” and whether the company appropriately notified consumers that certain products also contain wheat.

Consumers and food producers will soon see major changes to food safety regulations in the United States as the sweeping Food Safety Modernization Act (“FSMA”) begins to take effect. Signed into law during 2011, FSMA is designed to transform the federal food regulation scheme from a reactive process to a more proactive process that imposes more front-end safety checks on food producers, including farmers. President Obama signed FSMA shortly after the Peanut Corporation of America was found responsible for a major salmonella outbreak that sickened countless people and resulted in at least nine deaths. According to the investigation, executives at the Peanut Corporation of America were aware that the products contained salmonella when they released them into the consumer food chain.

If you or someone you love has suffered illness as the result of a contaminated food or foodborne illness, you may be entitled to compensation. At Moll Law Group, we have represented many plaintiffs throughout the United States, including in California, New York, and Illinois. We know just how difficult this experience can be for you and your family, and how daunting it can seem to bring a lawsuit against a big company. Our lawyers will stand by you through every step of the process and ensure that you receive the personalized and diligent representation that you deserve. Call us now at 312-462-1700 or contact us online to set up your free consultation.

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