District Court Enters Injunction Against Michigan Cheese Manufacturer and Its Owners to Prevent Distribution of Adulterated Cheese
The U.S. District Court for the Eastern District of Michigan entered an injunction against S. Serra Cheese Company (Serra Cheese), of Clinton Township, Michigan, and its co-owners, Stefano Serra and Fina Serra, to prevent the distribution of adulterated cheese, the Department of Justice announced today.
The department filed a complaint on Aug. 8, 2014, in the U.S. District Court for the Eastern District of Michigan, at the request of the U.S. Food and Drug Administration (FDA). According to the complaint, S. Serra Cheese Company prepares, processes and distributes several varieties of pasteurized, ready-to-eat cheeses, such as ricotta, provolone, mozzarella and primo sale. The complaint alleged that the company’s Italian cheeses are manufactured in insanitary conditions and that the company’s procedures are inadequate to ensure the safety of its products.
The injunction announced today followed an Oct. 20, 2015, decision by the district court that Serra Cheese violated the Food, Drug and Cosmetic Act by distributing adulterated, ready-to-eat cheese products. The company sells these products to customers in Michigan, Illinois, New York and Pennsylvania.
“The Department of Justice is committed to preventing the unlawful distribution of adulterated food and enforcing laws designed to protect consumer health and safety,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Department of Justice’s Civil Division. “The Department of Justice will continue to work with the FDA to enforce laws designed to protect the American people from adulterated food.”
The district court’s Oct. 20, 2015, decision concluded that inspections by the FDA in 2013 showed that Serra Cheese repeatedly introduced adulterated cheese into interstate commerce and caused the cheese to become adulterated while held for sale after shipment in interstate commerce. The inspections, which occurred in January and November 2013, resulted in the collection of samples that showed that Listeria innocua was present in numerous locations throughout Serra Cheese’s facility. Analysis of other samples showed significant levels of non-pathogenic E. coli in the finished cheese products, indicating exposure of the products, directly or indirectly, to feces.
Furthermore, according to the district court’s Oct. 20, 2015, decision, Serra Cheese’s own testing, conducted in March 2015, revealed the presence of Listeria spp. at multiple locations in the company’s facility, including on its production floor.
The injunction requires Serra Cheese to take specific steps to remedy the violations found by the court. The defendants are required to submit a written plan to test the cheese in its existing inventory to detect the presence of certain microorganisms. In addition, defendants are required to conduct ongoing testing of certain finished cheese products pursuant to a plan approved by FDA. If, as part of the ongoing testing of finished cheese products, any such product tests positive for L. mono or pathogenic E. coli, defendants must immediately cease production and distribution and notify FDA that production and distribution have ceased.
In addition, under the injunction, the defendants must submit to the FDA a sanitation program that establishes adequate methods, facility and controls for receiving, preparing, processing, packing, holding, and distributing articles of food to minimize the risk of introduction of pathogenic Listeria or any other poisonous or deleterious substances, or contamination with filth, to ensure that defendants’ foods are not adulterated under the Act. For example, the plan must include thoroughly cleaning, sanitizing, renovating and rendering the facility and all equipment suitable for use in receiving, preparing, processing, packing, holding and distributing articles of food to prevent such articles from becoming adulterated and instituting standard sanitation operating procedures to ensure that the facility and equipment are continuously maintained in a sanitary condition.
The government is represented by Trial Attorney David A. Frank of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan of the Eastern District of Michigan, with the assistance of Associate Chief Counsel Yen Hoang of the U.S. Department of Health and Human Services’ Office of General Counsel’s Food and Drug Division.