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FDA seeks permanent injunction against Michigan cheese manufacturer

UPDATE: On October 20, 2015, Judge Avern Cohn of the United States District Court for the Eastern District of Michigan issued an order finding that S. Serra Cheese Company, of Clinton Township, Michigan had violated the Federal Food, Drug and Cosmetic Act by repeatedly selling adulterated ready-to-eat cheese. The company makes and sells a variety of cheeses to customers in Michigan, Illinois, New York and Pennsylvania. The court found that FDA test results had revealed nonpathogenic Listeria innocua in numerous locations at the facility, indicating that life-threatening pathogens such as Listeria monocytogenes are likely to grow and flourish in the same facility. The court also noted that FDA had found significant levels of nonpathogenic E. coli in several of the company’s finished cheese products, indicating exposure of the products either directly or indirectly to feces. Although the company claims to have taken corrective actions, the court noted that recent samples taken from the facility still detected Listeria and indicate that the changes have not been adequate. To date, the company continues to make and sell cheese despite these findings. No illnesses have been reported to date associated with these products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator. The case number is US-DIS-MIED 2:14cv13077 and can be found on pacer.gov.

For Immediate Release

August 11, 2014

Release

On August 8, 2014, the U.S. Department of Justice, at the request of the U.S. Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Eastern District of Michigan against S. Serra Cheese Company, of Clinton Township, Michigan, and its owners, Stefano Serra and Fina Serra.

According to the complaint, FDA laboratory testing conducted in 2013 found non-pathogenic E. coli in S. Serra Cheese’s finished cheese products and Listeria innocua in the company’s facility. The presence of L. innocua indicates unsanitary conditions and an environment that could support the growth of L. monocytogenes, an organism that poses a life-threatening health hazard because it is the causal agent for the disease listeriosis. The complaint also alleges that FDA inspections since 2013 documented the failure to implement effective monitoring and sanitation controls in accordance with the current “Good Manufacturing Practice” requirements for food. In June 2013, the FDA issued a warning letter to the company.

The complaint requests, among other things, that the court issue an order for permanent injunction prohibiting Serra Cheese from receiving, preparing, processing, packing, holding or distributing food until the company brings their operations into compliance with the law.

“When a company ignores warnings or refuses to address food safety issues that put consumers at risk, the FDA must take action,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The FDA protects public health by enforcing regulations that require companies to handle and prepare food products in accordance with good manufacturing procedures.”

No illnesses have been reported to date associated with S. Serra Cheese products. Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.

The company manufactures and distributes a variety of pasteurized cheeses including ricotta, provolone, mozzarella and primo sale cheeses in Michigan, Illinois, New York and Pennsylvania.

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.

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Page Last Updated: 11/09/2015
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