FDA WARNING_LETTER - Flores Produce, Inc. - March 11, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Flores Produce, Inc. from March 8-11, 2022, following a previous inspection in October 2020. The inspection aimed to determine compliance with section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. The FDA found significant violations, specifically that Flores Produce, Inc. failed to develop, maintain, and follow an FSVP for papayas imported from (b)(4), as required by 21 CFR 1.502(a). This means the firm did not perform the necessary risk-based activities to verify that imported food meets U.S. food safety standards. The FDA also noted that papayas are "covered produce," requiring the FSVP to demonstrate supplier compliance with produce safety standards under 21 CFR part 112. The firm did not respond to the Form FDA 483a issued. Flores Produce, Inc. must respond in writing within fifteen working days, detailing corrective actions, providing documentation of an implemented FSVP, and explaining any delays. Failure to address these violations could result in refusal of admission for imported food, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.