The US Food and Drug Administration (FDA) have taken action against food manufacturer Native American Enterprises due to repeated violations of US food and safety laws.
The US District Court for Kansas ordered a consent decree of permanent injunction against the Wichita based company after it routinely flouted federal food laws
The US Department of Justice brought the action on behalf of the FDA for significant and ongoing violations of federal food safety laws and regulations.
A consent decree of permanent injunction has been entered between the US District Court for the District of Kansas, the US and the Native American Enterprises, its part-owner William N. McGreevy, and its production manager Robert C. Conner.
The injunction prevents Native American Enterprises from selling FDA-regulated products until it comes into compliance with the relevant regulation.
FDA Listeria finding
The complaint, filed by the Department of Justice at the request of the FDA, alleges the Kansas food manufacturer’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 RTE food may have become contaminated with filth or have been rendered injurious to health’.
The complaint said the ‘insanitary conditions‘ included the presence of Listeria Monocytogene (L. mono) in the Wichita-based company’s facility, and insanitary employee practices.
The agency used Whole Genome Sequencing (WGS) to identify persistent strains of L. mono.
The FDA inspected the Native American Enterprises facility in August 2015 and observed numerous insanitary practices. These included: a failure to manufacture and package food under the conditions necessary to minimize microorganism growth; and a failure to take necessary precautions to protect against contamination and maintain the site’s buildings in good repair.
The FDA also observed rain water leaking through the factory roof in the packaging room directly above where the RTE refried beans were being packaged, as well as cracks and holes in the walls and floor junctures that allow water and debris to collect and which prohibited adequate cleaning and could harbor Listeria.
Not the first case of Listeria
The FDA also inspected the Wichita facility twice in 2014, and as alleged in the complaint found Listeria in the facility collected from the environmental samples it collected from RTE refried beans production during its two inspections.
The FDA complaint also alleged the Kansas company failed to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing, as observed by the regulatory body.
FDA’s associate commissioner for regulatory affairs, Melinda K. Plaisier, said the action taken against Native American Enterprises was necessary in the interests of public health.
“When a company repeatedly violates food safety laws and procedures they are putting the public at serious risk,” she said.
“The FDA took action against Native American Enterprises to protect public health, and as a result, the company’s adulterated food products are prevented from entering the marketplace.”
As well as its RTE refried beans and sauces, Native American Enterprises also manufactures meat and poultry products which fall under US Department of Agriculture Food and Safety and Inspection Service (USDA-FSIS) regulations
The consent decree does not apply to USDA-FSIS regulated products, but the agency investigated the company’s manufacturing site and it is operating under an enforcement verification plan when producing its meat and poultry products which fall under the agencies regulations.
The consent decree of permanent injunction requires Native American Enterprises to cease all manufacture or distribution of food including refried beans and sauces, but not its meat products.
The FDA’s recent action against Native American Enterprises follows the regulatory body issuing a letter to Native American Enterprises in August 2013 warning the company to promptly correct its violations or potentially face legal action.
No illnesses have been reported from Native American Enterprises products.