Old Europe Cheese, Inc.
Outcome
Old Europe Cheese, Inc. of Benton Harbor, Michigan, voluntarily recalled all Brie and Camembert cheeses and halted production in September–October 2022 after FDA inspection found Listeria monocytogenes in the facility matching the outbreak strain; the multistate outbreak caused 6 illnesses and 5 hospitalizations across multiple states; FDA subsequently issued a warning letter for serious CGMP and preventive controls violations.
Details
Old Europe Cheese, Inc. — Listeria / Brie & Camembert Recall / Production Halt (2022)
Outcome: Old Europe Cheese, Inc. voluntarily recalled all Brie and Camembert cheeses and halted production at its Benton Harbor, Michigan facility in September–October 2022 after FDA inspection confirmed Listeria monocytogenes in the facility matched the outbreak strain; the investigation linked the facility to a multistate outbreak causing 6 illnesses, 5 hospitalizations, and no deaths; FDA subsequently issued a warning letter for serious CGMP and FSMA preventive controls violations.
Old Europe Cheese, Inc. operates a specialty cheese manufacturing facility in Benton Harbor, Michigan, producing Brie and Camembert soft cheeses distributed nationally under multiple brand names and private labels. The company's cheeses were sold at major retailers including Whole Foods, Safeway, and approximately a dozen other chains. In September 2022, FDA and CDC investigated a multistate cluster of Listeria monocytogenes infections.
FDA inspected the Benton Harbor facility from September 13 through October 6, 2022. The inspection revealed "serious violations of the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation." Environmental samples collected during the inspection tested positive for Listeria monocytogenes, and Whole Genome Sequencing confirmed the environmental strain matched the strain causing outbreak illnesses.
Old Europe Cheese issued its initial recall of Brie and Camembert cheeses on September 30, 2022, and expanded the recall on October 5, 2022, to include baked Brie products. A further expansion on November 4, 2022, added additional retail chains that had received bulk product. The company halted production and worked with FDA on corrective actions. FDA subsequently issued a warning letter documenting the CGMP and preventive controls violations. No deaths were reported in this outbreak.
Primary Source: Outbreak Investigation of Listeria monocytogenes: Brie and Camembert Soft Cheese Products (September 2022) | FDA
How Crucible Prevents This
Brie and Camembert soft cheeses are ready-to-eat high-risk products for Listeria under FDA's guidance; the preventive controls for these products require validated environmental monitoring and sanitation programs. Crucible's DECISIONS log would require the facility to document that the most recent environmental monitoring results were reviewed and showed no Listeria-positive findings before each production run. A facility with Listeria in the production environment that is selling directly to Whole Foods, Safeway, and a dozen other national retailers was operating with undetected or undisclosed environmental contamination — a gap that mandated daily environmental monitoring sign-off would close.
Don't let this happen to your organization. See how Crucible works.
See How Crucible Works