FDA WARNING_LETTER - Fresh Express Inc - Div of Chiquita Brands - July 23, 2020

The FDA inspected Fresh Express's Streamwood, IL bagged salad operation from June 25 to July 23, 2020, following a multistate cyclosporiasis outbreak affecting 701 people across 14 states, linked to the facility's bagged salad mixes. This was the second such outbreak associated with the facility since 2018. The presence of Cyclospora cayetanensis renders the products adulterated under 21 U.S.C. § 342(a)(1) as a poisonous substance and under 21 U.S.C. § 342(a)(4) due to insanitary conditions, indicating human fecal contamination. The letter cited a failure to adequately identify and implement preventive controls for hazards like Cyclospora in raw produce, as required by 21 CFR § 117.135(a)(1). The firm's existing Food Safety Plan and supplier verification activities were deemed insufficient. Additionally, Fresh Express caused delays in providing traceback documents to the FDA. The FDA recommends reanalyzing the Food Safety Plan, enhancing grower/harvester verification, focusing on human fecal contamination routes, and considering environmental surveillance. The firm must improve traceability systems and respond within 15 working days outlining corrective actions, with potential for further regulatory action and re-inspection fees if violations are not corrected.