FDA seeks permanent injunction against Michigan cheese manufacturer

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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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