USA – FDA Warning Letter – Old Europe Cheese, Inc. – Listeria monocytogenes


Dear Mr. Navarro,

The United States Food and Drug Administration (FDA) inspected your ready-to-eat (RTE) soft and semi-soft cheese manufacturing facility, located at 1330 E. Empire Avenue, Benton Harbor, MI, from September 13, 2022 through October 6, 2022. The inspection, conducted jointly with the Michigan Department of Agriculture and Rural Development (MDARD), was initiated as part of a multistate outbreak of Listeria monocytogenes (L. monocytogenes) infections linked to RTE soft cheese products supplied by your facility. According to the Centers for Disease Control and Prevention (CDC), six (6) ill people from six (6) states were infected with the outbreak strain of L. monocytogenes. On September 30, 2022, your firm recalled all RTE Brie and Camembert Soft Cheese products because they had the potential of being contaminated with L. monocytogenes. On October 5, 2022 your firm expanded the recall to also include Baked Brie Cheeses. One (1) environmental swab isolate collected by FDA during our inspection of your manufacturing facility matched the clinical outbreak isolates, based on Whole Genome Sequencing (WGS) analysis. According to the CDC, epidemiologic, traceback, and laboratory data showed that cheese made by Old Europe Cheese, Inc. made people sick.

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