Gongora USA Corp – FDA Warning Letter, Nov 15, 2024

On January 2, 2025, the FDA issued a Warning Letter to Gongora USA Corp following Foreign Supplier Verification Program (FSVP) inspections conducted from November 14-15, 2024, and previously from December 1, 2020, to January 13, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandates importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, including fresh produce potentially classified as "covered produce" under 21 CFR 112.3. This constitutes a significant violation of Section 805 of the FD&C Act and 21 CFR 1.502(a). The company received a Form FDA 483a FSVP Observations on November 15, 2024, but no response was received.

The FDA warns that 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, potential detention without physical examination (DWPE) for foods from identified foreign suppliers, and prohibition of importation under Section 301(zz