Case 6:16-cv Document 1 Filed 03/21/16 Page 1 of 9 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF KANSAS

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1 Case 6:16-cv Document 1 Filed 03/21/16 Page 1 of 9 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF KANSAS UNITED STATES OF AMERICA, ) ) Plaintiff, ) CIVIL ACTION NO ) v. ) ) NATIVE AMERICAN ENTERPRISES, ) COMPLAINT FOR PERMANENT LLC, a limited liability company, and ) INJUNCTION WILLIAM N. MCGREEVY, and ) ROBERT C. CONNER, ) individuals, ) ) Defendants. ) Plaintiff, the United States of America, by its undersigned counsel, respectfully represents to this Court as follows: INTRODUCTION 1. The United States of America brings this action under the Federal Food, Drug, and Cosmetic Act (the Act ), 21 U.S.C. 332(a), and the inherent equitable authority of this Court, to permanently enjoin and restrain Native American Enterprises, LLC, William N. McGreevy, and Robert C. Conner (collectively, Defendants ), from violating: (1) 21 U.S.C. 331(a), by introducing and causing to be introduced into interstate commerce, and delivering and causing to be delivered for introduction into interstate commerce, food that is adulterated within the meaning of 21 U.S.C. 342(a)(4); and (2) 21 U.S.C. 331(k), by causing food to become adulterated within the meaning of 21 U.S.C. 342(a)(4), while such food is held for sale after shipment of one or more components in interstate commerce. JURISDICTION AND VENUE 2. This Court has jurisdiction over this matter under 21 U.S.C. 332(a) and 28 1

2 Case 6:16-cv Document 1 Filed 03/21/16 Page 2 of 9 U.S.C. 1331, 1337, and Venue in this District is proper pursuant to 28 U.S.C. 1391(b) and (c). DEFENDANTS 4. Defendant Native American Enterprises, LLC ( NAE ) is a limited liability Kansas company that manufactures, processes, prepares, packs, holds, labels, and distributes ready-to-eat ( RTE ) food products, namely refried beans and sauces, from its facility located at 230 N. West Street, Wichita, Kansas 67203, within the jurisdiction of this Court. Defendants also manufacture meat products, including RTE Taco Filling with Meat, which are regulated by the United States Department of Agriculture ( USDA ). 5. Defendant William McGreevy is Vice President, and owns 49% of NAE, is responsible for the daily operations of the firm, and is ultimately responsible for the facility s sanitation and maintenance. He works on-site at the NAE facility in Wichita, Kansas, and resides in Kansas, within the jurisdiction of this Court. 6. Defendant Robert C. Conner is NAE s Production Manager. He has worked for NAE for five years as a team lead and is responsible for the refried bean production. He is the most responsible person at the firm when the William McGreevy is away. He directs production personnel and reports directly to Defendant William McGreevy. Defendant Conner works onsite at the NAE facility in Wichita, Kansas, and resides in Kansas, within the jurisdiction of this Court. LISTERIA MONOCYTOGENES 7. Listeria Monocytogenes ( L. mono ) is a bacterium found in soil and moist environments. 2

3 Case 6:16-cv Document 1 Filed 03/21/16 Page 3 of 9 8. L. mono is one of the leading causes of death from foodborne illness. Food contaminated with L. mono may cause many adverse health effects, including listeriosis. Individuals with weakened immune systems, such as pregnant women, the elderly, infants, and persons with immune systems impaired by disease or medications, face the greatest risk when eating food contaminated with L. mono. 10. L. mono thrives in moist environments, such as food-manufacturing environments, where, unless proper precautions are taken, it may become established and grow. It is difficult to eliminate once it becomes established in a food-manufacturing environment and is capable of surviving and growing at refrigerated temperatures and in high-salt environments. Consequently, L. mono is a significant public health risk in RTE refried beans and sauces. DEFENDANTS VIOLATIONS 9. Defendants violate 21 U.S.C. 331(a) by introducing, and delivering for introduction, into interstate commerce articles of food that are adulterated within the meaning of 21 U.S.C. 342(a)(4). 10. Defendants violate 21 U.S.C. 331(k) by causing food held for sale after shipment of one or more components in interstate commerce to become adulterated within the meaning of 21 U.S.C. 342(a)(4). 11. Defendants RTE refried beans and sauces are food within the meaning of 21 U.S.C. 321(f). 12. Defendants deliver their food products to distributors in Missouri and Kentucky. See 21 U.S.C. 321(b). 3

4 Case 6:16-cv Document 1 Filed 03/21/16 Page 4 of Defendants purchase and receive ingredients for their RTE refried beans and sauces, including pinto beans, tomato paste, and vegetable oil from a food supplier located in Texas which ships these ingredients to Defendants from its warehouse in Oklahoma. 14. Defendants food is adulterated within the meaning of 21 U.S.C. 342(a)(4), in that it has been prepared, packed, and/or held under insanitary conditions whereby it may have become contaminated with filth or have been rendered injurious to health. The insanitary conditions include the presence of L. mono in the NAE facility and insanitary employee practices. FDA INSPECTIONS 15. Inspections of the NAE facility by the United States Food and Drug Administration ( FDA ) have established that Defendants have an extensive history of operating under insanitary conditions and continue to violate the Act. August 2015 Inspection 16. FDA conducted its most recent inspection between August 5 and 20, FDA investigators collected environmental samples and observed numerous insanitary practices during this inspection, including, but not limited to, Defendants failure to: (a) Manufacture and package food under conditions necessary to minimize microorganism growth. FDA investigators took an environmental sample during RTE refried bean production. This sample consisted of 100 subsamples, 34 of which tested positive for L. mono, and five of which tested positive for other species of Listeria. (b) Take necessary precautions to protect against contamination. Defendants employees transferred dirty equipment between the raw room, where meat is processed, and the packaging room where RTE refried beans are packaged. Similarly, the floor 4

5 Case 6:16-cv Document 1 Filed 03/21/16 Page 5 of 9 in the raw room tested positive for L. mono, yet employees were observed dragging a hose across the raw room floor into the packaging room. (c) Maintain buildings in good repair. Specifically, FDA investigators observed rain water leaking through the roof in the packaging room, directly above where Defendants employees packaged RTE refried beans. FDA investigators also observed cracks and holes in the walls and floor junctures that allow water and debris to collect, prohibit adequate cleaning, and could harbor Listeria. 17. At the close of the inspection, the investigators issued a Form FDA-483, List of Inspectional Observations ( FDA 483 ), to Defendant William McGreevy. 18. NAE responded to the FDA 483 by on September 1, 2015, but its response failed to show that it had taken adequate steps to prevent the risks of L. mono contamination. For example, NAE proposed to conduct monthly environmental testing, which is insufficient to address the persistent and widespread L. mono contamination. Previous FDA Inspections 19. FDA conducted its initial inspection of the NAE facility between June 24 and July 19, 2013 after USDA informed FDA that it had tested Defendants RTE Taco Filling with Meat product and detected L. mono in the finished product. During this inspection, FDA collected an environmental sample that consisted of 85 subsamples, five of which tested positive for L. mono. 20. FDA inspected the NAE facility two additional times in 2014: September 23 October 15, 2014 and February 12 March 4, FDA investigators collected environmental samples during RTE refried bean production during each of these inspections and found Listeria in the NAE facility during each. FDA investigators also observed violative sanitation practices during each of the agency s prior inspections similar to those observed during the most recent 5

6 Case 6:16-cv Document 1 Filed 03/21/16 Page 6 of 9 inspection, including, but not limited to Defendants failure to maintain equipment in an acceptable condition through appropriate cleaning and sanitizing. 21. FDA investigators verbally discussed their observations with Defendant William McGreevy at the close of each of FDA s inspections and issued FDA 483 to him documenting their observations. 22. Although Defendants corrected some of the violations noted on the FDA 483s, Defendants have failed to prevent the presence of L. mono and create viable sanitation practices that prohibit microorganism growth, as demonstrated by the most recent inspection where FDA investigators found 34 sub-samples that tested positive for L. mono. DEFENDANTS NOTICE OF VIOLATIONS 23. FDA has repeatedly warned NAE about the violative conditions at its facility. FDA investigators issued FDA 483s to Defendants after each of the four FDA inspections. Additionally, after every inspection, FDA investigators discussed the observed violations with Defendant William McGreevy. 24. FDA also issued NAE a Warning Letter on August 9, This letter documented the insanitary conditions at the facility, warned that the firm s food items were adulterated within the meaning of 21 U.S.C. 342(a)(4), and informed Defendants that FDA could take further action if the firm continued in its violations, including injunction and/or seizure. 25. On March 25, 2014, FDA s Kansas City District Office held a regulatory meeting with Defendant William McGreevy, which was also attended by USDA representatives. During this meeting, FDA investigators reminded Defendant William McGreevy of the firm s regulatory 6

7 Case 6:16-cv Document 1 Filed 03/21/16 Page 7 of 9 responsibilities and discussed the importance of identifying the root cause of the L. mono in the NAE facility. 26. NAE has been warned repeatedly of the insanitary conditions and that continued violations could lead to regulatory action. Despite NAE s repeated promises to implement corrections, NAE has failed to institute the practices and procedures necessary to prevent insanitary conditions and practices and to control the L. mono contamination. Based on NAE s persistent violations in the face of multiple prior warnings, Plaintiff is informed and believes that, unless restrained by order of the Court, Defendants will continue to violate 21 U.S.C. 331(a) and (k). PRAYER FOR RELIEF WHEREFORE, Plaintiff respectfully requests that this Court: I. Permanently restrain and enjoin, under 21 U.S.C. 332(a), Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with any of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates), who receive notice of the Court s order from, directly or indirectly: A. violating 21 U.S.C. 331(a), by introducing, delivering, and causing the introduction and delivery for introduction into interstate commerce any article of food that is adulterated within the meaning of 21 U.S.C. 342(a)(4); and B. violating 21 U.S.C. 331(k), by doing and causing to be done any act that causes any article of food to become adulterated within the meaning of 21 U.S.C. 342(a)(4), while such article is held for sale after shipment of one or more of its components in interstate commerce; 7

8 Case 6:16-cv Document 1 Filed 03/21/16 Page 8 of 9 II. Order Defendants and each and all of their directors, officers, agents, representatives, employees, attorneys, successors, assigns, and any and all persons in active concert or participation with any of them (including individuals, directors, partnerships, corporations, subsidiaries, and affiliates), who receive notice of the Court s order to cease, directly or indirectly, receiving, processing, manufacturing, preparing, packaging, holding, and distributing any article of food within the meaning of 21 U.S.C. 321(f), at or from the NAE facility (and any other or new location at or from which Defendants receive, process, manufacture, prepare, pack, hold, or distribute food), unless and until Defendants bring their operations into compliance with the Act and its implementing regulations to the satisfaction of FDA; and III. Award the United States its costs herein, including the costs of investigations to date, and such other relief as the Court may deem just and proper. Dated this 21 st day of March, Respectfully submitted, OF COUNSEL: WILLIAM B. SCHULTZ General Counsel ELIZABETH H. DICKINSON Chief Counsel Food and Drug Division PERHAM GORJI Deputy Chief Counsel, Litigation SONIA W. NATH Associate Chief Counsel for Enforcement United States Department of Health and Human Services Office of the General Counsel Food and Drug Administration BARRY R. GRISSOM United States Attorney District of Kansas Emily Metzger Assistant United States Attorney District of Kansas 1200 Epic Center 301 N. Main Wichita, KS BENJAMIN C. MIZER Principal Assistant Attorney General Civil Division MICHAEL S. BLUME Director Consumer Protection Branch 8

9 Case 6:16-cv Document 1 Filed 03/21/16 Page 9 of 9 White Oak 31, Room New Hampshire Avenue Silver Spring, MD s/ Heide L. Herrmann HEIDE L. HERRMANN Consumer Protection Branch Civil Division United States Department of Justice P.O. Box 386 Washington, DC