After being linked to a Listeria outbreak in 2022, Old Europe Cheese suspended operations and received an FDA warning letter. The outbreak, which sickened six people in six states- California, Georgia, Massachusetts, Michigan, New Jersey, and Texas, triggered a recall that included cheeses sold under more than two dozen brand names. The recalled cheeses were sold at dozens of stores nationwide including Albertsons, Fresh Thyme, Hannaford, Hy-Vee, Jewel-Osco, Meijer, Safeway, Target, Trader Joe’s, Whole Foods, and Winn Dixie.
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FDA’s Inspection of Old Europe Cheese
Health officials used genetic testing on Listeria samples collected from the patients who were sickened between August 2017 and August 2022 and found they matched each other and the Listeria strain found in the Benton Harbor, MI manufacturing facility of Old Europe Cheese Inc.
From September 13, 2022, through October 6, 2022, the U.S. Food and Drug Administration (FDA) inspected the facility and found “serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventative Controls for Human Food regulation,” according to the letter. Because of these findings, the FDA determined that the ready-to-eat (RTE) brie and camembert soft cheeses manufactured at the facility were adulterated and should not enter interstate commerce.
The company suspended operations while it conducted a roost cause investigation, attempted to correct problems cited in the FDA’s inspection report, “implement long-term infrastructure projects and rebuild its food safety systems.” These corrective measures included cleaning, environmental sector sampling, hiring a food safety consultant, and making improvements to the ceilings, walls, floors, and drains.
But these actions, outlined in emails to the FDA on October 28, 2022, November 30, 2022, January 13, 2023, and February 28, 2023, were not sufficient for the FDA because the company did not show that the measures had eliminated Listeria from the facility. This prompted the agency to issue a warning letter.
FDA’s Warning Letter to Old Europe Cheese
In its warning letter to Old Europe Cheese, FDA cites the following problems:
- Failure to appropriately evaluate known or reasonably foreseeable hazards to determine whether they require a preventive control.
- Failure to demonstrate that any hazards requiring a preventive control will be significantly minimized or prevented so that cheese products will not be adulterated.
- Failure to clean, sanitize and sterilize utensils and equipment in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.
- Failure to address the physical properties of the plant that cause condensate to drip from fixtures, ducts, and pipes which can contaminate food and food-contact surfaces.
The FDA gave Old World Cheese 15 days to respond to the letter which is dated April 4, 2023.
Experienced Listeria Lawyers
If you developed a Listeria infection after eating recalled cheese and would like to discuss your legal options, please contact our Listeria lawyers. Our Food Safety Team has more experience handling Listeria lawsuits than any other law firm in the country securing some of the largest Listeria settlements in U.S. history including a recent award of $6.4 million.
You can reach us by calling 1-888-377-8900, sending a text to 612-261-0856, or completing the form below. There is no obligation and we don’t get paid unless we win.