October 23, 2016

FDA Warning Letter to Preferred Meal Systems of Illinois

The FDA sent a warning letter to Preferred Meal Systems in Illinois in February 2016, detailing violations of Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food (CGMP) regulation. FDA inspectors collected environmeal samples that found Listeria monocytogenes in the facility. That facility makes ready-to-eat cold cut sandwiches and boxed lunches, for which there is zero tolerance for Listeria contamination. They also make non-RTE cooked frozen entrees and side dishes.

Cold Cut SandwichThe swabs that were positive for Listeria monocytogenes were taken in the Airline Production Room on the floor under the tomato sauce filler, in a square shaped hole, on the bottom of a shovel, in the floor drain, and on the floor near the roll up door to the dock area. In addition, they found Listeria in the School Lunch Program Room of the facility, on the sponge part of a blue squeegee, on the wheel of the tomato sauce hopper, and on a step stool.

The presence of Listeria monocytogenes bacteria in the facility is significant because “it demonstrates the sanitation efforts are inadequate to effectively control pathogens in your facility to prevent contamination of food,” according to the letter. Listeria can cause serious illness and death, especially in children, the elderly, pregnant women, their babies, and those with compromised immune systems.

The facility was informed that Listeria was found during an inspection in August, 2015. In the February letter, the FDA states “your response is inadequate.” The owner of the company did not provide details of corrective actions taken to fix the problem.

And that’s not all. Other violations were observed during FDA inspections. An employee used a high pressure host to clean the side of a production line, which caused the water to aerosolize into the air near a line that was making cheese tortellini. A gap was found on a metal cart that could allow for debris to become trapper, which could lead to contamination.

Inspectors also found water leaking from pipes above food tanks and into process food products, especially ready-to-eat foods, which violates the requirement to handle work-inporgress in a way that protects against contamination. And the plans provided by the company does not address the sanitation or protection of food contact equipment when condensate drips from the ceiling onto that equipment.

Also, employees entered the production room from the employee break room without washing their hands. Some of those who did wash their hands only rinsed their hands with water and did not use soap. Hand washing facilities were not adequate, and the temperature in the faucets was too cold.

The facility is also poorly maintained. Peeling floor paint and deteriorated areas of flooring were found in many processing areas. Water was accumulating on the concrete and under the floor, which provides a growth medium for Listeria bacteria. The walls of the facility were also deteriorating and chipping.

Inspectors also found significant violations of the Seafood HACPP regulation, including no hazard analysis for each kind of fish product produced. there was an inadequate plan to monitor the ambient air temperature of the cooler used to store fish.


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