A federal court ordered to Michigan-based food manufacturer to discontinue selling food products until the company complies with federal regulations and other requirements. This action follows several inspections conducted by the US Food and Drug Administration and Michigan Department of Agriculture and Rural Development, which found Listeria monocytogenes (L. mono) in the company's food preparation area.

US District Judge Paul L. Maloney for the Western District of Michigan entered a consent decree of permanent injunction on Nov. 30, 2018, between the US and Saranac Brand Foods, and the company's co-owners, Dennis M. Nowak and Daniel R. Nowak. Saranac Brand Foods specialized in manufacturing a variety of 35 different ready-to-eat foods including prepared salads, dips and willows.

The consent decree prohibits the defendants from receiving, preparing, processing, packing, holding, labeling and distributing foods at or from their facility, or any other facility, until specific requirements are met.

The defendants told the court they discontinued all food operations in August 2018 and intended to dissolve the company. If the defendants choose to resume activities, the consent decree requires them to notify the FDA and take corrective actions before restarting operations. "The FDA and the Michigan  Department of Agriculture and Rural Development have documented a pattern of food safety violations at this facility, and the inappropriate and unsafe practices of Saranac Brand Foods.

Not only violated the law but also put consumers in harm's way, "said FDA Associate Commissioner for Regulatory Affairs Melinda Plaisier." This type of behavior is unacceptable to the FDA and is why we took action to prevent the defendants from introducing contaminated or potentially contaminated food products into the marketplace. "

FDA

According to the complaint, filed by the US Department of Justice on behalf of the FDA, and state officials inspected the facility several times since 2012 and found L. mono in the facility during three separate inspections. The inspections also documented that the defendants were processing food under unsanitary conditions, in violation of the Federal Food, Drug, and Cosmetic Act (FD & C Act). L. mono is a pathogenic bacterium that can cause listeriosis, a rare but potentially life-threatening illness. People with compromised immune systems, the elderly, pregnant women and developing fetuses are particularly susceptible to listeriosis.

The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and safety of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.