A federal court ordered a 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 U.S. 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.
U.S. District Judge Paul L. Maloney for the Western District of Michigan entered a consent decree of permanent injunction on Nov. 30, 2018, between the U.S. 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 sauces.
The consent decree prohibits the defendants from receiving, preparing, processing, packing, holding, labeling and/or distributing foods at or from their facility, or any other facility, until certain requirements are met. The defendants told the court they discontinued all food operations in August 2018 and intend to dissolve the company. If the defendants choose to resume operations, the consent decree requires them to notify the FDA and take corrective actions before resuming operations.
"The FDA and the Michigan Department of Agriculture and Rural Development have documented a pattern of food safety violations at this facility. 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."
According to the complaint, filed by the U.S. Department of Justice on behalf of the FDA, 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 insanitary 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.
In August 2016, the FDA issued the defendants a Warning Letter, informing them of the L. mono contamination and objectionable conditions at the facility. The Warning Letter emphasized the serious nature of the deficiencies and stated that it was the defendants' responsibility to ensure that their products comply with the FD&C Act. In November 2017, the FDA's investigators issued the defendants a list of inspectional observations that identified insanitary conditions observed during a follow-up inspection.
Consumers are encouraged to contact the FDA to report problems with any FDA-regulated products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is 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.