FDA WARNING_LETTER - Garcia Fresh Vegetables LLC - December 03, 2024

On January 27, 2025, the FDA issued a Warning Letter to Garcia Fresh Vegetables LLC following a Foreign Supplier Verification Program (FSVP) inspection on December 3, 2024, at their McAllen, Texas facility. Previous inspections occurred in November 2019 and April 2022.

The inspection revealed significant violations of section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the implementing FSVP regulation (21 CFR part 1, subpart L). Specifically, Garcia Fresh Vegetables LLC failed to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). This includes fresh produce, which may be "covered produce" under 21 CFR 112.3, necessitating an FSVP demonstrating supplier compliance with U.S. produce safety standards (21 CFR part 112).

The company received a Form FDA 483a FSVP Observations on December 3, 2024, but has not submitted a response. Failure to adequately address these violations may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, placement of foods on detention without physical examination (DWPE) via Import Alert #99-41, and prohibition of importation under section 3