A consent decree of permanent injunction has been entered between the US, the firm; its part-owner, William N. McGreevy; and production manager, Robert C. Conner.
The move prevents the firm from selling FDA-regulated products until it comes into compliance with the relevant regulation.
It also manufactures meat and poultry products, which fall under US Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) regulations.
The consent decree does not apply to USDA-FSIS regulated products but the agency investigated the site and the company is operating under an enforcement verification plan when producing such items.
Alleged adulteration
The complaint alleges 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’.
No illnesses have been reported from Native American Enterprises’ products.
Native American Enterprises (NAE) is involved in food processing and manufacturing from a facility in Wichita, Kansas.
Target markets include USDA Commodity School Lunch Contracts, US Military Prime Vendor Contracts, US Military Field Rations, proprietary chains, co-packing and private labeling, local retails stores, and Direct Store Delivery (DSD) in the Wichita and surrounding areas.
NAE said it was ‘pleased’ to have resolved the matter and has hired a sanitation company.
“The company has significantly improved its Listeria testing since FDA raised this issue, and has implemented additional sanitation processes including hiring a professional sanitation company, Q-Vest.
“Since hiring Q-Vest and implementing additional sanitation and testing procedures, no Listeria has been identified in NAE’s facility. NAE uses a “hot fill” manufacturing process to further minimize the risk of foodborne pathogens.
“No illnesses have been reported from any of NAE’s food products, and the safety of its products continues to be NAE’s highest priority.”
Warning letter and inspection
FDA said it issued a letter to NAE in August 2013 warning the company to correct its violations or potentially face legal action.
The agency added it did several follow-up inspections of the processing facility and continued to observe unsanitary conditions at the facility, including unsanitary employee practices and persistent strains of Listeria Monocytogenes (L. mono).
It used Whole Genome Sequencing (WGS) to identify persistent strains of L. mono.
“Listeria Monocytogenes is a very dangerous bacteria, and its presence in a food production facility is of great concern,” said Benjamin C. Mizer, head of the Department of Justice’s Civil Division.
FDA inspected the facility in August 2015 collecting environmental samples, and observed insanitary practices.
Acording to the complaint, FDA observed rain water leaking through the roof in the packaging room, directly above where NAE employees packaged RTE refried beans and cracks and holes in the walls and floor junctures that allow water and debris to collect and stop adequate cleaning.
Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs, said: “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.”