An El Abuelito Cheese Listeria warning letter was sent to the company by the FDA in June, 2020. This is the brand that may be associated with the current Listeria monocytogenes outbreak linked to Hispanic-style soft and fresh cheeses that has sickened seven people in four states, according to testing conducted by the Connecticut Department of Health.
The letter states that after an FDA inspection, a Form FDA-483 was issued that found the facility was not in compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (CGMP & PC).
Government officials found “serious violations” of the CGMP & PC rule, according to the El Abuelito Cheese Listeria warning letter, because the owner, operator, or agent in charge of the covered facility did not comply with the preventive controls provisions stated in the rule.
Inspectors found that the company did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at the facility to identify and evaluate known or reasonably foreseeable hazards. Environmental pathogens such as Listeria monocytogenes and Salmonella were not identified and evaluated. The facility makes ready to eat foods that are exposed to the environment before packaging. This is important since Listeria is an environmental pathogen that is a “known or reasonably foreseeable hazard for cheeses,” in particular soft cheeses such as queso fresco.
The company did not establish and implement preventive controls to ensure that hazards would be significantly minimized or prevented and that the food will not be adulterated. When ready to eat foods are produced, sanitation controls are needed to control pathogens such as Listeria monocytogenes.
The company responded and said they are working with a HACCP consultant to develop a food safety plan. The FDA stated they will assess the adequacy and implementation of the food safety plan during the next inspection.
During the inspection, investigators collected environmental swabs from different locations around the processing areas. Analysis confirmed that two swabs tested positive for Listeria grayi and Listeria innocua, non-pathogenic Listeria species. The presence of these species indicates that conditions are conducive for pathogenic Listeria monocytogenes to be present in the facility. The company did not conduct swabbing for Listeria species at the time, according to the warning letter.
At this time the FDA is conducting whole genome sequencing (WGS) on the Listeria monocytogenes found in the El Abuelito queso fresco cheese by the Connecticut DOH. We don’t know if it is the same pathogen that made people sick in the current outbreak.
If you or a loved one have been sickened with a Listeria monocytogenes infection after eating Hispanic-style soft and fresh cheeses, please contact our experienced attorneys for help at 1-888-377-8900 or 612-338-0202.
