December 4, 2016

Consent Decree Issued Against Native American Enterprises

The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction last week between the United States and Native American Enterprises of Wichita, Kansas. The action was brought for “significant and ongoing violations of federal food safety laws and regulations.”

Gavel on Bench

The government alleges that the company’s ready to eat refried beans and sauces are adulterated, in that they have been prepared, packed, or held under unsanitary conditions so the food is contaminated with filth or has been rendered injurious to health. The company can no longer sell any FDA regulated products until it comes into compliance with the Federal Food, Drug, and Cosmetic Act.

The company was sent a warning letter in August 2013, telling the owners to correct its violations or face legal action. Several follow-up inspections of the facility were conducted. Inspectors found unsanitary practices, including unsanitary employee practices and persistent strains of Listeria monocytogenes. There is zero tolerance for Listeria bacteria in ready to eat foods.

Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, said in a statement, “when a company repeatedly violates food safety laws and procedures they are putting the public at serious risk. The FDA took action against Native American Enterprises, LLC to protect public health, and as a result, the company’s adulterated food products are prevented from entering the marketplace.”

The company must retain an independent laboratory to collect and analyze samples for the presence of Listeria bacteria, hire an independent sanitation expert, and develop a program to control the bacteria and eliminate unsanitary conditions at its facility. The FDA maintains oversight over their operations and may order the company to take corrective actions if the company can resume operations in the future.

No illnesses have been reported from products made by the company to date. Anyone who has eaten products made by this company should see a doctor if they develop the symptoms of listeriosis. Those symptoms include high fever, severe headache, nausea, abdominal cramps, stiff neck, diarrhea, and muscle aches.

The company also makes meat and poultry products, which fall under USDA regulations. The consent decree does not apply to those products, but the USDA recently conducted an investigation at the establishment. The company is operating under an FSIS enforcement verification plan when producing USDA-regulated products.

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