The Food and Drug Administration warned El Abuelito Cheese Inc. owners about the presence of Listeria in their manufacturing facility eight months ago in June 2020. The company has recently recalled many cheese products in relation to a current outbreak.
El Abuelito soft cheese are the suspected source of the current Listeria monocytogenes outbreak that has, as of the most recent update from the Centers for Disease Control and Prevention, sickened 10 people. Nine of them have been so sick they required hospitalization. Patients are spread across five states. The most recent person to be confirmed infected became sick Feb. 9.
This number will most likely grow as there can be a delay of a month or more in the infection testing and reporting process before patients are added to outbreak totals. Also, it can take up to 70 days after exposure to the bacterium before symptoms develop.
The FDA warning letter was issued in June this past year and details a routine FDA inspection performed in February 2020. Warning letters often are not issued until a company has been given months to years to correct problems identified during inspections. Companies are given 15 business days to respond to warning letters.
During the inspection of the El Abuelito Cheese Inc.’s manufacturing facility, the FDA collected environmental swabs from various locations throughout processing areas. Two swaps tested positive for Listeria grayi and Listeria innocua.
According to the warning letter, “the presence of Listeria spp. indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in (El Abuelito Cheese Inc.’s) facility.”
The FDA recommends that consumers, restaurants, and retailers should not eat, sell, or serve any El Abuelito brand cheeses. This includes, but is not limited to, the recalled El Abuelito cheeses. Additionally, the FDA adds that consumers should not eat, sell, or serve any recalled Rio Grande and Rio Lindo brand queso fresco cheeses.
The warning letter includes the following information.
El Abuelito Cheese Inc.
A cheese company in New Jersey is on notice from the FDA after inspectors found non-pathogenic Listeria species in its manufacturing facility.
In a June 4, 2020, warning letter the FDA described a Jan. 14 through Feb. 6, 2020, inspection at El Abuelito Cheese Inc.’s ready-to-eat cheese manufacturing facility. During the inspection, FDA investigators found serious violations of the Current Good Manufacturing Practice Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation.
The FDA’s inspection resulted in issuance of an FDA Form 483. The significant violations are as follows:
Hazard Analysis and Risk-Based Preventive Controls:
- The firm did not conduct a hazard analysis for each type of food manufactured, processed, packed, or held at their facility to identify and evaluate known or reasonably foreseeable hazards to determine whether there are any hazards requiring a preventive control. Specifically, the firm did not identify and evaluate environmental pathogens, such as Listeria monocytogenes and Salmonella, to determine whether environmental pathogens are a hazard requiring a preventive control. Their facility manufactures RTE food which is exposed to the environment prior to packaging. The packaged food does not receive a treatment or otherwise include a control measure (such as a formulation lethal to the pathogen) that would significantly minimize the pathogen. Listeria monocytogenes is an environmental pathogen that is a known or reasonably foreseeable hazard for cheeses, in particular soft cheeses such as queso fresco.
- The firm did not establish and implement preventive controls to provide assurances that any hazards requiring a preventive control will be significantly minimized or prevented and the food manufactured, processed, packed, or held by their facility will not be adulterated. Preventive controls include, as appropriate to the facility and the food, process controls, food allergen controls, sanitation controls, supply-chain controls, and a recall plan. For example, for the processing of RTE foods exposed to the environment, generally sanitation controls are needed to control environmental pathogens such as Listeria monocytogenes. Preventive controls are subject to preventive control management components as appropriate to ensure the effectiveness of the preventive controls, taking into account the nature of the preventive control and its role in the facility’s food safety system.
- They did not prepare or have prepared and did not implement a written food safety plan for any of the products manufactured in their facility. A food safety plan must include the following:
- The written hazard analysis;
- The written preventive controls;
- The written supply-chain program;
- The written recall plan;
- The written procedures for monitoring the implementation of the preventive controls;
- The written corrective action procedures;
- The written verification procedures.
The firm’s response indicates that they are working with a HACCP consultant to develop their food safety plan for their facility. The FDA will assess the adequacy and implementation of their food safety plan during the next FDA inspection.
In addition to the violations described above, the FDA offered the following comments:
- During their inspection, the FDA collected environmental swabs from various locations throughout their processing areas. FDA laboratory analysis of the environmental sample INV1123037 collected on January 15, 2020 confirmed two (2) swabs positive for Listeria grayi and Listeria innocua; both are non-pathogenic Listeria species (Listeria spp.). One of the positive swabs was collected from a surface adjacent to a food-contact surface on the (redacted) edges of the (redacted) conveyor belt. Additionally, FDA laboratory analysis of the environmental sample INV1123040 collected on January 29, 2020 confirmed one (1) swab positive for Listeria innocua. The presence of Listeria spp. indicates that the conditions are conducive for pathogenic Listeria monocytogenes to be present in their facility. The firm only tests their environment for ATP and coliforms; they do not conduct swabbing for Listeria spp., which is an appropriate indicator organism for Listeria monocytogenes. As noted above, Listeria monocytogenes is a known or reasonably foreseeable hazard for cheese; sanitation controls are generally applied to prevent contamination of RTE food such as cheese from the environment, and environmental monitoring for Listeria spp. is usually used to verify these controls.
- During FDA inspection, investigators made observations regarding the potential need for the monitoring of certain aspects of their operation, which would need to be assessed when their firm evaluates the need to establish and implement preventive control programs. Specifically, they do not monitor their sanitizer solution to ensure concentration levels are effective for their (redacted) sanitizer at the production entry door, their (redacted) of sanitizer containing white rags used to wipe down equipment, or their buckets of sanitizer used to soak utensils.
- The FDA notes that part 117 includes requirements for training employees and keeping records of certain training. The firm’s response states that they (redacted). However, their response does not include details on when this (redacted) will occur or the records documenting that this (redacted) was conducted. The FDA will verify the adequacy during their next inspection.
The full warning letter can be viewed here.
About Listeria infections
Food contaminated with Listeria monocytogenes may not look or smell spoiled but can still cause serious and sometimes life-threatening infections. Anyone who has eaten any recalled cheese and developed symptoms of Listeria infection should seek medical treatment and tell their doctors about the possible Listeria exposure.
Also, anyone who has eaten any of the recalled products should monitor themselves for symptoms during the coming weeks because it can take up to 70 days after exposure to Listeria for symptoms of listeriosis to develop.
Symptoms of Listeria infection can include vomiting, nausea, persistent fever, muscle aches, severe headache, and neck stiffness. Specific laboratory tests are required to diagnose Listeria infections, which can mimic other illnesses.
Pregnant women, the elderly, young children, and people such as cancer patients who have weakened immune systems are particularly at risk of serious illnesses, life-threatening infections, and other complications. Although infected pregnant women may experience only mild, flu-like symptoms, their infections can lead to premature delivery, infection of the newborn, or even stillbirth.
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