June 16, 2021

Fresh Express Cyclospora Warning Letter Sent by FDA

The FDA has sent a Fresh Express cyclospora warning letter as part of the investigation into the multistate foodborne illness outbreak of cyclosporiasis in the summer of 2020. The outbreak sickened at least 701 people in 14 states. The Centers for Disease Control and Prevention (CDC) and the FDA determined that Fresh Express bagged salad mixes that contained iceberg lettuce, carrots, and red cabbage was the source of this outbreak. There was also a Fresh Express cyclospora outbreak in 2018 associated with McDonald’s salads that sickened more than 500 people.

Fresh Express Cyclospora Warning Letter Sent by FDA

The product in question was manufactured at the company’s facility in Streamwood, Illinois. The presence of Cyclospora cayetanensis in the bagged salads cause them to be adulterated per the Federal Food, Drug, and Cosmetic Act. Because the only known reservoir of this parasite is in the human gut, that means that the product has been in direct or indirect contamination with human feces.

The FDA inspected the Streamwood facility and issued a Form FDA 483, which is filed when the government finds violations of food safety regulations.

The government found that the company tested for the parasite, but stated that “this testing was not performed as part of your verification activities for the control of the hazard of Cyclospora cayetanensis, but rather to better understand the parasite and potential control mechanisms.” The FDA said that the company should reanalyze their Food Safety Plan to detained whether the preventive controls and grower/harvester verification activities are enough to ensure control of the parasite.

In addition, the FDA experienced delays in Fresh Express’ response to requests for documents used in the traceback investigation. It took a week after the FDA asked Fresh Express to recall the product and share tracing information for them to comply. Fresh Express also needs to improve traceability systems and processes, along with the speed and accuracy by which the company complies with records and information requested by the government.

Pritzker Hageman Food Safety Lawyers

If you or a loved one have been sickened with a cyclospora infection after eating recalled Fresh Express bagged salads, please contact our experienced attorneys for help at 1-888-377-8900 or 612-338-0202.

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