USA – Fresh Express Inc – Div of Chiquita Brands – FDA Warning Letter

FDA

The U.S. Food and Drug Administration (FDA ) inspected your bagged salad operation located at 1109 East Lake Street, Streamwood, IL 60107, from June 25, 2020 through July 23, 2020. The inspection was initiated as part of an investigation of a multistate foodborne outbreak of cyclosporiasis (human infections with the parasite Cyclospora cayetanensis). As of September 23, 2020, the Centers for Disease Control and Prevention (CDC) reported that at least 701 people from 14 states have been infected with Cyclospora cayetanensis. Based on epidemiological and traceback evidence, CDC and FDA have determined that bagged salad mixes containing iceberg lettuce, carrots, and red cabbage manufactured at your Streamwood, IL facility were the source of this multistate cyclosporiasis outbreak. On June 19, 2020, you recalled bagged salad mix containing iceberg lettuce, red cabbage, and carrots, because they had the potential to be contaminated with Cyclospora. The Public Health Agency of Canada is also investigating an outbreak of cyclosporiasis infections occurring in three Canadian provinces in which Fresh Express brand salad products containing iceberg lettuce, carrots, and red cabbage have been identified as the likely source of the outbreak. This is the second outbreak of cyclosporiasis linked to Fresh Express product. In 2018, a multistate foodborne outbreak of cyclosporiasis involving 511 confirmed cases from 15 states was linked to salads sold at a fast food restaurant and manufactured at your Streamwood, IL facility.