A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division.
S. Serra Cheese Company manufactures and distributes several varieties of Italian cheeses, such as ricotta, provolone, mozzarella and primo sale. The complaint alleges 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 department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).
“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Assistant Attorney General Delery. “The Department of Justice will continue to bring enforcement actions against food manufacturers who do not follow the necessary procedures to comply with food safety laws.”
According to the complaint, two FDA inspections performed in 2013 revealed that the company’s cheese is adulterated within the meaning of the Food, Drug and Cosmetic Act because it is prepared, packed or held under insanitary conditions in which it may have become contaminated with filth or rendered injurious to health. The complaint alleges, for example, that the company repeatedly failed to reduce the risk of contamination from two potentially dangerous types of bacteria: Escherichia coli (E. coli) and Listeria innocua (L. innocua).
Although the strains of E. coli found in cheese samples collected from the company’s facility were n on-pathogenic, their presence indicates that the facility is insanitary and contaminated with filth. In addition, t he presence of L. innocua indicates insanitary conditions and a work 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, a serious encephalitic disease. The presence of L. innocua in the company’s facility demonstrates the potential for the presence of L. monocytogenes in the same processing environment.
According to the complaint, the FDA’s most recent inspection in November 2013 revealed insanitary conditions, including the presence of generic, non-pathogenic E. coli and L. innocua and the absence of effective monitoring and sanitation controls in accordance with the current Good Manufacturing Practice requirements for food under federal law. For example, cleaning and sanitizing operations for utensils and equipment were not performed in a manner that protects against contamination of food and food contact surfaces.
FDA previously inspected the facility in January 2013. According to the complaint, at that time, FDA inspectors discovered a number of Good Manufacturing Practice deficiencies. For example, FDA inspectors noted that the facility was not constructed in such a manner as to allow floors to be adequately cleaned and to be kept clean and in good repair. The FDA inspectors also observed that the company failed to store raw materials in a manner that protects against contamination.
The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan for the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.
A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.