The complaint alleges that the company’s Italian cheeses are manufactured in unsanitary conditions, and that its procedures are inadequate to ensure the safety of products.
S. Serra Cheese Company manufactures and distributes Italian cheeses, such as ricotta, provolone, mozzarella and primo sale.
The department filed the injunction action in federal court at the request of the US Food and Drug Administration (FDA) against the company and its owners, Stefano and Fina Serra.
According to the complaint, the FDA’s most recent inspection in November 2013 revealed unsanitary conditions, including the presence of non-pathogenic E. coli and Listeria innocua (L. innocua) and the absence of effective monitoring and sanitation controls.
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, said the filing.
According to the complaint, two FDA inspections in 2013 revealed that the company’s cheese is adulterated because it is prepared, packed or held under unsanitary conditions in which it may have become contaminated with filth or rendered injurious to health.
The complaint alleges that the company repeatedly failed to reduce the risk of contamination from E. coli and L. innocua.
Although the strains of E. coli found in cheese samples from the facility were non-pathogenic, their presence indicates that it is unsanitary and contaminated with filth.
Potential for L. monocytogenes findings
The presence of L. innocua in the facility demonstrates the potential for the presence of L. monocytogenes in the same processing environment, said the complaint.
“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Stuart Delery, assistant attorney general of the Justice Department’s Civil Division.
FDA previously inspected the facility in January 2013.
According to the complaint, FDA inspectors discovered a number of Good Manufacturing Practice deficiencies.
They noted that the facility was not constructed 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.
“Laboratory analysis found non-toxigenic E. coli in levels ranging from 23->1100 most probable number (MPN) per gram per sub in three finished product samples of Sundried tomato cheese, Fresh cherry Mozzarella cheese and Hot Red Pepper Cheese,” said a warning letter sent to the firm in June 2013.
The presence of non-toxigenic E.coli in dairy products at levels higher than 10 MPN/g in two or more subsamples as found, causes the finished products to be adulterated, added the agency.
Listeria innocua, a non-pathogenic microorganism, was also found from six locations in the facility.