The cheese producer pleaded guilty to a misdemeanor violation of the federal Food, Drug and Cosmetic Act (FDCA).
The company and two co-owners, Ana A. Roos and Virginia Mejia, also entered into a civil agreement called a consent decree of permanent injunction.
According to that, if Roos Foods or the two individuals want to begin producing and distributing food in the future, they can do so only if the FDA confirms operations comply with the FD&C Act and all applicable food safety regulations.
Link to Listeria outbreak
Cheese produced by Roos Foods was linked to an outbreak of L. mono that sickened eight people (Seven from Maryland and one in California) in 2013 with the investigation continuing into the following year.
Seven of the eight were hospitalized and one death was reported in California.
The FDA suspended the facility’s registration in March 2014, which barred them from introducing food into interstate commerce.
“The FDA will not tolerate food companies that fail to provide adequate safeguards and place the public health at risk by producing and shipping contaminated products,” said Howard Sklamberg, FDA’s deputy commissioner for Global Regulatory Operations and Policy.
Roos Foods made ready-to-eat cheeses such as ricotta, queso fresco and fresh cheese curd, and had customers in Delaware, Maryland, New Jersey, New York, Virginia and Washington DC.
FDA inspection findings
An FDA inspection revealed sanitation deficiencies, such as widespread roof leaks in the manufacturing area, including over open manufacturing equipment; rust flakes on the manufacturing equipment from corroded roof trusses and metal roofing; uncleanable surfaces on walls, floors and ceilings and product residue on equipment that had purportedly been cleaned.
The agency also collected environmental samples on site and found L. mono on 12 surfaces.
Pulsed-field gel electrophoresis (PFGE) showed that 11 of the 12 L. monocytogenes isolates from the FDA environmental samples collected on February 18, 2014, were indistinguishable from the clinical isolates associated with the outbreak.
Charles M. Oberly III, US Attorney for the District of Delaware, said it is cases such as this that demonstrate the need for government regulations concerning food safety.
“Manufacturers of our nation’s food supplies must comply with the law and when violators are found they should expect to be prosecuted and, if necessary, put out of business.”