FDA WARNING_LETTER - AMORE PRODUCE LLC - February 05, 2025

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Amore Produce, LLC from February 03-05, 2025, following a previous inspection in 2023. The inspection aimed to assess 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 Amore Produce, LLC failed to develop, maintain, and follow an FSVP as required by section 805 of the FD&C Act and 21 CFR 1.502(a). This includes not having an FSVP for foods imported from foreign suppliers, particularly fresh produce that may be considered “covered produce” under 21 CFR 112.3. The firm did not respond to the Form FDA 483a issued on February 05, 2025. Failure to adequately address these violations may lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement on Detention Without Physical Examination (DWPE), and prohibition of importation under section 301(zz). Amore Produce, LLC must respond in writing within fifteen working days, detailing corrective actions, including documentation of changes, a copy of their FSVP, and records demonstrating its implementation.