FDA takes action against Kansas food manufacturer for repeated food safety violations

The U.S. Department of Justice brought the action on behalf of the U.S. Food and Drug Administration for significant and ongoing violations of federal food safety laws and regulations. The complaint alleges that the company’s ready-to-eat (RTE) refried beans and sauces are adulterated in that they have been prepared, packed and/or held under unsanitary conditions whereby the food may have become contaminated with filth or have been rendered injurious to health.

Native American Enterprises, LLC is a manufacturer and distributor of a variety of food, including RTE refried beans and sauces falling under FDA jurisdiction. The consent decree prevents the company from selling FDA-regulated products until it comes into compliance with the Federal Food, Drug, and Cosmetic Act (the Act).

The company also manufactures meat and poultry products, which fall under U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) regulations. While the consent decree does not apply to USDA-regulated products, the FDA and USDA FSIS have and will continue to work closely together. USDA FSIS recently performed an investigation at the establishment and the company is currently operating under an FSIS enforcement verification plan when producing USDA-regulated products.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, and products that give off electronic radiation, and for regulating tobacco products.

SOURCE U.S. Food and Drug Administration