Delaware-based cheese manufacturer Roos Foods, Inc. has pleaded guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act) by introducing adulterated food into interstate commerce.
The company and two co-owners have also entered into a civil agreement called a consent decree of permanent injunction. According to that decree, 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 that their operations comply with the FD&C Act and all applicable food safety regulations.
Roos Foods, Inc. made ready-to-eat Hispanic-style cheese products such as ricotta, queso fresco, and fresh cheese curd, and had customers in Delaware, Maryland, New Jersey, New York, Virginia, and Washington, D.C. In February and March 2014, Roos Foods voluntarily recalled all lots, sizes and types of cheese distributed under the Amigo, Anita, Mexicana, and Santa Rose de Lima brands.
Cheese produced by Roos Foods, Inc. was linked to an outbreak of Listeria monocytogenes (L. mono) that sickened eight people in 2013. Seven of the eight ill persons were hospitalized. Five of the illnesses were related to a pregnancy; two of these were diagnosed in two mother–newborn pairs, and one in only the newborn. The three other illnesses occurred among adults. One death was reported in California. All ill persons were reported to be of Hispanic ethnicity.
The FDA suspended Roos Foods, Inc.’s facility registration on March 11, 2014, which barred the company from introducing food into interstate commerce. The agency’s order of suspension details sanitation problems and cites findings of L. mono contamination in multiple places in the facility.
The FDA inspected the company’s facility from February 18 – March 4, 2014. During the inspection, FDA investigators found insanitary conditions including:
- The roof leaking so badly that water was raining down into the cheese processing room, including onto the cheese processing equipment and storage tanks;
- Standing water on the floor throughout the cheese curd processing room in proximity to the cheese vats and in the storage rooms;
- Metal roof/ceiling and metal supports exhibiting a rusted appearance with metal flaking precluding effective cleaning and sanitizing;
- Food residues found on equipment after cleaning had been performed;
- Openings to milk storage tanks and transfer piping were not capped to prevent contaminants from entering or contaminating food contact surfaces; and
- Floors, wall, and equipment that were deteriorated and in bad repair, including processing equipment and storage vats with rust holes and floors with rough concrete deterioration.
Additionally, the FDA collected environmental samples from different areas of the facility, including the cheese processing room and various pieces of equipment. FDA's testing identified 12 swabs that tested positive for Listeria monocytogenes, and pulsed-field gel electrophoresis (PFGE) analysis showed that 11 of those swabs had the same Listeria monocytogenes "DNA-fingerprint" as the outbreak strain.
Listeriosis can be fatal, especially in certain high-risk groups. These groups include the elderly, and people with weakened immune systems and certain chronic medical conditions (such as cancer). In pregnant women, listeriosis can cause miscarriage, stillbirth, premature labor, and serious illness or death in newborn babies, even though the mother rarely becomes seriously ill.
“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 the FDA’s Deputy Commissioner for Global Regulatory Operations and Policy Howard Sklamberg. “We will continue to work with the Department of Justice to use the full force of our justice system against those that place profits over the health and safety of American consumers.”
“We must work to ensure that the food we buy is free from dangerous bacteria and is safe to eat,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work aggressively to combat and deter conduct leading to the distribution of adulterated food to consumers.”
See the FDA Announcement
See the FDA Outbreak Report
See also Medical Law Perspectives, July 2012 Report: Foodborne Illness: When Grabbing a Bite Can Be Deadly