FDA WARNING_LETTER - ZACANTA LLC - January 27, 2025

The FDA conducted Foreign Supplier Verification Program (FSVP) inspections of ZACANTA LLC on July 14-18, 2023, and January 14-27, 2025, at 10700 S Sugar Rd, Pharr, TX. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandate risk-based activities for importers to verify foreign food safety standards.

The FDA found ZACANTA LLC non-compliant with FSVP requirements, specifically failing to develop, maintain, and follow an FSVP for any imported foods, including fresh produce potentially classified as "covered produce." This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act. A Form FDA 483a FSVP Observations was issued on February 6, 2025, to which no response has been received.

Failure to address these violations may lead to further FDA action, including refusal of admission for imported food under Section 801(a)(3) of the FD&C Act, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under Section 301(zz) of the FD&C Act. ZACANTA LLC must respond in writing within