Michigan Company Enjoined from Distributing Products

The complaint alleged that analysis of environmental samples collected from the defendants' facility during numerous inspections showed the facility contained a resident strain of Listeria monocytogenes. FDA most recently inspected the facility in late 2017, and its inspection showed the ready-to-eat food products that defendants manufactured and distributed were adulterated.

The U.S. Department of Justice announced Dec. 3 that a federal court has permanently enjoined a Saranac, Mich., company and its owners from preparing, processing, and distributing adulterated ready-to-eat food. In a complaint filed on November 29, 2018, at the request of the U.S. Food and Drug Administration, the government alleged defendants Saranac Brand Foods, Inc., and its owners, Dennis M. Nowak and Daniel R. Nowak, violated the Federal Food, Drug, and Cosmetic Act by introducing or delivering for introduction into interstate commerce ready-to-eat food that was adulterated.

The complaint alleged Saranac prepared and distributed approximately 35 different ready-to-eat foods, including prepared salads, dips, and sauces such as coleslaw, macaroni salad, spinach dip, and enchilada sauce.

The complaint alleged that analysis of environmental samples collected from the defendants' facility during numerous inspections showed the facility contained a resident strain of Listeria monocytogenes. FDA most recently inspected the facility in late 2017, and its inspection showed the ready-to-eat food products that defendants manufactured and distributed were adulterated in that they were prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health.

"The Department of Justice is committed to ensuring that processors and distributors of ready-to-eat food products comply with laws designed to protect consumers," said Assistant Attorney General Jody Hunt of the DOJ Civil Division. "The Department of Justice will continue to work with the FDA to ensure that consumers are protected from potentially unsafe food."

"We all reasonably expect that ready-to-eat foods are, in fact, ready to eat — that they have been prepared in a clean environment and in a way that does not potentially expose the food to dangerous bacteria," said U.S. Attorney Andrew B. Birge for the Western District of Michigan. "Saranac Brands fell short of that reasonable expectation, so the Department of Justice, including my office, put a stop to their practices."

The defendants agreed to settle the complaint and be bound by a consent decree for permanent injunction. As part of the settlement, the defendants represented that they have discontinued all operations related to receiving, preparing, processing, holding, or distributing any articles of food at or from their business location and any other location. Under the permanent injunction, if the defendants intend to resume such activity, they must notify FDA in writing in advance, comply with specific remedial measures set forth in the injunction, and allow FDA to inspect their facility, including the buildings, sanitation-related systems, equipment, utensils, all articles of food, and relevant records.

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