FDA WARNING_LETTER - Troya Del Campo USA LLC - August 02, 2024

On September 4, 2024, the FDA issued a Warning Letter to Troya Del Campo USA LLC following Foreign Supplier Verification Program (FSVP) inspections conducted from February 8-14, 2023, and August 1-2, 2024. The inspections, aimed at determining compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, revealed significant violations.

The primary violation is the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods, including avocado, cilantro, broccoli, and mango from various foreign suppliers. As an importer of "covered produce," Troya Del Campo USA LLC must have an FSVP demonstrating that suppliers meet U.S. food safety standards, specifically those under 21 CFR Part 112 (Standards for Produce Safety).

The FDA noted that a Form FDA 483a FSVP Observations was issued on August 2, 2024, and no response has been received. Failure to adequately address these violations may result in refusal of admission of imported food under Section 801(a)(3) of the FD&C Act, placement on detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under Section 301(zz