The U.S. District Court for the District of Kansas entered a consent decree of permanent injunction today between the United States and Native American Enterprises, LLC, located in Wichita, Kansas; its part-owner, William N. McGreevy; and its production manager, Robert C. Conner.
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 FDA issued a letter to Native American Enterprises, LLC in August 2013 warning the company to promptly correct its violations or potentially face legal action. The FDA conducted several follow-up inspections of the company’s food processing facility and continued to observe unsanitary conditions at the facility, including unsanitary employee practices and persistent strains of Listeria Monocytogenes(L. mono), a dangerous human pathogen that can cause listeriosis, a life-threatening illness. People with compromised immune systems, the elderly, pregnant women, and developing fetuses are particularly susceptible to listeriosis.
The FDA used Whole Genome Sequencing (WGS) to identify persistent strains of L. mono at Native American Enterprises, LLC. WGS technology can show the relationship among isolates of bacterial pathogens found in the environment, a food source, or a person who became ill from consuming contaminated food.
“When a company repeatedly violates food safety laws and procedures they are putting the public at serious risk,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “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.”
Under the consent decree, the company cannot prepare, process, manufacture, pack, and/or label FDA-regulated food products until it demonstrates that its facility and processing equipment are suitable to prevent contamination. Native American Enterprises, LLC must, among other things, retain an independent laboratory to collect and analyze samples for the presence of L. mono, retain an independent sanitation expert and develop a program to control L. mono and to eliminate unsanitary conditions at its facility. Should the company be permitted to resume operations in the future, the FDA maintains oversight over such operations under this consent decree and may order the company to take corrective actions if the agency discovers further food safety violations.
To date, no illnesses have been reported from Native American Enterprises, LLC’s products. Individuals who have eaten products purchased from the company should contact a health care professional if they experience any symptoms of listeriosis. In addition, consumers are encouraged to contact the FDA to report problems with FDA-regulated products.
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.