Wednesday, June 1, 2016
The
U.S. District Court for the District of Kansas entered a consent decree
of permanent injunction against Native American Enterprises LLC (NAE),
of Wichita, Kansas; its vice president and part-owner, William N.
McGreevy; and its production manager, Robert C. Conner, to stop the
distribution of adulterated food, the Department of Justice announced
today.
The department filed a complaint in the District of Kansas on March 21, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, NAE manufactures and distributes ready-to-eat (RTE) refried beans and sauces. The complaint alleged that the company’s RTE refried beans and sauces are adulterated in that they have been prepared, packed and/or held under insanitary conditions whereby the food may have become contaminated with filth or have been rendered injurious to health. According to the complaint, the insanitary conditions include the presence of Listeria Monocytogenes (L. mono) in NAE’s facility and insanitary employee practices.
“Listeria Monocytogenes is a very dangerous bacteria, and its presence in a food production facility is of great concern,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to ensure a safe food supply.”
On May 27, the parties filed a consent decree of permanent injunction, by which the defendants agreed to resolve the litigation. The consent decree of permanent injunction, entered by the district court, requires the defendants to cease all manufacture or distribution of food (including RTE refried beans and sauces) other than meat products. Meat products are regulated separately by the U.S. Department of Agriculture (USDA). In the event that defendants intend to resume the manufacture or distribution of food other than meat products, they will only be allowed to do so with FDA approval and under strict supervision. The defendants will also be required to destroy, under FDA’s supervision, any such products already in existence.
With respect to meat products, USDA’s Food Safety Inspection Service (FSIS) conducts daily on-site operations inspections at all firms manufacturing USDA FSIS regulated products pursuant to the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act.
According to the complaint filed in this matter, FDA inspected NAE’s facility, located at 230 N. West Street in Wichita, in August 2015, collected environmental samples, and observed numerous insanitary practices, including the defendants’ failure to manufacture and package food under conditions necessary to minimize microorganism growth, take necessary precautions to protect against contamination and maintain buildings in good repair.
Specifically, according to the complaint, FDA observed rain water leaking through the roof in the packaging room, directly above where NAE employees packaged RTE refried beans. In addition, FDA observed cracks and holes in the walls and floor junctures that allow water and debris to collect, prohibit adequate cleaning and could harbor Listeria, according to the complaint.
FDA inspected NAE’s facility twice in 2014. As alleged in the complaint, FDA collected environmental samples during RTE refried beans production during each of the 2014 inspections and found Listeria in the facility. In addition, as alleged in the complaint, FDA also observed a failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
As alleged in the complaint, L. mono thrives in moist environments, such as food-manufacturing environments. Unless proper precautions are taken, L. mono may become established and grow and it is difficult to eliminate once it becomes established in a food-manufacturing environment. It is capable of surviving and growing at refrigerated temperatures and in high-salt environments. The complaint alleges that L. mono is a significant public health risk in RTE refried beans and sauces.
The government is represented by Trial Attorney Heide L. Herrmann of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Emily Metzger of the U.S. Attorney’s Office for the District of Kansas, with the assistance of Associate Chief Counsel for Enforcement Sonia W. Nath of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Kansas, visit its website at https://www.justice.gov/usao-ks.
The department filed a complaint in the District of Kansas on March 21, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, NAE manufactures and distributes ready-to-eat (RTE) refried beans and sauces. The complaint alleged that the company’s RTE refried beans and sauces are adulterated in that they have been prepared, packed and/or held under insanitary conditions whereby the food may have become contaminated with filth or have been rendered injurious to health. According to the complaint, the insanitary conditions include the presence of Listeria Monocytogenes (L. mono) in NAE’s facility and insanitary employee practices.
“Listeria Monocytogenes is a very dangerous bacteria, and its presence in a food production facility is of great concern,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work aggressively with the FDA to ensure a safe food supply.”
On May 27, the parties filed a consent decree of permanent injunction, by which the defendants agreed to resolve the litigation. The consent decree of permanent injunction, entered by the district court, requires the defendants to cease all manufacture or distribution of food (including RTE refried beans and sauces) other than meat products. Meat products are regulated separately by the U.S. Department of Agriculture (USDA). In the event that defendants intend to resume the manufacture or distribution of food other than meat products, they will only be allowed to do so with FDA approval and under strict supervision. The defendants will also be required to destroy, under FDA’s supervision, any such products already in existence.
With respect to meat products, USDA’s Food Safety Inspection Service (FSIS) conducts daily on-site operations inspections at all firms manufacturing USDA FSIS regulated products pursuant to the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act.
According to the complaint filed in this matter, FDA inspected NAE’s facility, located at 230 N. West Street in Wichita, in August 2015, collected environmental samples, and observed numerous insanitary practices, including the defendants’ failure to manufacture and package food under conditions necessary to minimize microorganism growth, take necessary precautions to protect against contamination and maintain buildings in good repair.
Specifically, according to the complaint, FDA observed rain water leaking through the roof in the packaging room, directly above where NAE employees packaged RTE refried beans. In addition, FDA observed cracks and holes in the walls and floor junctures that allow water and debris to collect, prohibit adequate cleaning and could harbor Listeria, according to the complaint.
FDA inspected NAE’s facility twice in 2014. As alleged in the complaint, FDA collected environmental samples during RTE refried beans production during each of the 2014 inspections and found Listeria in the facility. In addition, as alleged in the complaint, FDA also observed a failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing.
As alleged in the complaint, L. mono thrives in moist environments, such as food-manufacturing environments. Unless proper precautions are taken, L. mono may become established and grow and it is difficult to eliminate once it becomes established in a food-manufacturing environment. It is capable of surviving and growing at refrigerated temperatures and in high-salt environments. The complaint alleges that L. mono is a significant public health risk in RTE refried beans and sauces.
The government is represented by Trial Attorney Heide L. Herrmann of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Emily Metzger of the U.S. Attorney’s Office for the District of Kansas, with the assistance of Associate Chief Counsel for Enforcement Sonia W. Nath of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the District of Kansas, visit its website at https://www.justice.gov/usao-ks.