The U.S. Justice Department (DOJ) filed a civil complaint in Michigan federal court on Friday against S. Serra Cheese Co. of Clinton Township, MI, and owners Stefano and Fina Serra, to prevent the distribution of allegedly adulterated cheese products. The complaint was filed by request from the U.S. Food and Drug Administration (FDA).
The DOJ claims that the company’s Italian cheeses, including ricotta, provolone, mozzarella and primo sale, are manufactured in “insanity conditions” and that the firm’s procedures “are inadequate to ensure the safety of its products.”
“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Assistant Attorney General Stuart Delery of the DOJ’s Civil Division. “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.”
Such a complaint sets out the government’s allegations, and, if the case were to proceed to trial, the government would need to prove them by a preponderance of the evidence.
Two FDA inspections in 2013 found that the company “repeatedly failed to reduce the risk of contamination from two potentially dangerous types of bacteria: Escherichia coli and Listeria innocua,” according to the complaint.
“Although the strains of E. coli found in cheese samples collected from the company’s facility were non-pathogenic, their presence indicates that the facility is insanitary and contaminated with filth,” the complaint states. “In addition, the 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.”
Results of FDA inspections of the facility in January 2013 were detailed in a June 6, 2013, warning letter addressed to Fina Serra as the co-owner and manager of the company. The letter noted a number of “serious violations” of Current Good Manufacturing Practices, the non-toxigenic E. coli test results, structural problems in the manufacturing plant, and inadequate cleaning and sanitation practices.
The DOJ complaint further states that the most recent FDA inspection this past November found that “cleaning and sanitizing operations for utensils and equipment were not performed in a manner that protects against contamination of food and food contact surfaces.”
Fina Serra reportedly responded to FDA’s letter, but the agency did not find her response to be sufficient.
The government is represented by 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.