July 22, 2018

FDA’s Anti-Listeria Enforcement Lingers at Roos Foods Cheese Plant

The Maryland queso Listeria outbreak that also killed a person in California is over as stated by the CDC, but a related suspension order at the Roos Foods plant in Delaware will stay in effect until the U.S. Food and Drug Administration vacates the order, a public affairs official for the FDA’s Investigations Branch in Philadelphia said.

Cheese Listera Lawyer“Until the FDA vacates the suspension order, the facility may not introduce food into commerce,” the FDA’s JuliAnn Putnam told Food Poisoning Bulletin.

For the FDA to vacate the suspension order, made on March 11, the agency would have to “make a determination that food manufactured, processed, packed, or held by the facility no longer has a reasonable probability of causing serious adverse health consequences,” Putnam said. Such a determination could be based on evidence that corrective actions have been taken, she said. One way the company may do this is by developing a corrective action plan and/or entering into a consent decree with the FDA through a court order, she said.

Roos Foods, a maker of cheese and dairy under brands including Mexicana, Santa Rosa de Lima, Suyapa and Amigo, was implicated as the likely source of the Maryland soft cheese Listeria outbreak following a collaborative investigation by local and state public health and regulatory agencies, CDC, and FDA.  The outbreak strain of Listeria monocytogenes that caused the illnesses was found in cheese products produced by Roos Foods, officials have said.

All patients in this outbreak were people of Hispanic heritage, including seven Marylanders who were hospitalized. One death was reported in California. Five of the illnesses (2 mother-newborn pairs and a newborn) were related to pregnancy. The outcome was in keeping with the dangerous and deadly profile of Listeria monocytogenes, a pathogen that is especially harmful to women during pregnancy. Soft cheese, including queso fresco, has been a vehicle for the organism in repeated outbreaks.

Listeria cheese litigation against Roos Foods in connection with this outbreak will center on the long list of contaminants, unkempt equipment, deplorable food plant conditions and lack of food safety protocols found by FDA investigators inside Roos Foods. Families affected by the outbreak have an opportunity to achieve some monetary compensation because of the thorough and effective food poisoning legal work carried out by authorities.

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