A federal court permanently enjoined a Saranac, Michigan company and its owners from preparing, processing, and distributing adulterated ready-to-eat food, the Department of Justice announced today.
In a complaint filed on November 30, 2018, at the request of the U.S. Food and Drug Administration (FDA), the United States alleged that defendants Saranac Brand Foods, Inc., and the company’s 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 that 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 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 Department of Justice’s 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 complaint alleged that analysis of environmental samples collected from defendants’ facility during numerous inspections showed that the facility contained a resident strain of Listeria monocytogenes (L. mono). FDA most recently inspected the facility in late 2017. According to the complaint, FDA’s inspection established that the ready-to-eat food products that defendants manufactured and distributed were adulterated in that they have been prepared, packed or held under insanitary conditions whereby they may have become contaminated with filth or rendered injurious to health. As alleged in the complaint, FDA collected environmental sub-samples that tested positive for L. mono, and also observed that the flooring in defendants’ facility’s food processing area was in poor repair with exposed aggregate, chipped areas, ponded water and debris.
Defendants agreed to settle the complaint and be bound by a consent decree for permanent injunction. The consent decree entered by the United States District Court for the Western District of Michigan permanently enjoins the defendants from violating the Federal Food, Drug, and Cosmetic Act. As part of the settlement, 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 locations. Under the permanent injunction, if 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.
“Taking steps to keep potentially unsafe food out of the U.S. food supply is a core responsibility of the FDA,” said Associate Commissioner for Regulatory Affairs Melinda K. Plaisier. “When a company fails to follow current good manufacturing practices and processes food under insanitary conditions, the FDA will take action to protect the public health and safety of Americans.”
Trial Attorney Claude Scott of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Ryan Cobb of the United States Attorney’s Office for the Western District of Michigan represented the United States, along with the assistance of Associate Chief Counsel Joshua Davenport of the Department of Health and Human Services’ Office of the General Counsel’s Food and Drug Division.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at https://www.justice.gov/civil/consumer-protection-branch. For more information about the U.S. Attorney’s Office for the Western District of Michigan, visit its website at https://www.justice.gov/usao-wdmi.
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