FDA WARNING_LETTER - Gonzar Produce, LLC - December 17, 2024

On March 3, 2025, the FDA issued a Warning Letter to Gonzar Produce, LLC, following Foreign Supplier Verification Program (FSVP) inspections on December 16-17, 2024, and July 18-19, 2023. The inspections revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, as the company failed to develop, maintain, and follow an FSVP for any imported foods, including fresh produce. This produce may be "covered produce" under 21 CFR 112.3, requiring an FSVP to ensure foreign suppliers meet U.S. food safety standards, specifically those in 21 CFR part 112.

The company also failed to register its facility at 2501 W. Military Hwy Suite B52, McAllen, TX 78503, as required by section 415 of the FD&C Act and 21 CFR part 1, subpart H. Failure to register is a prohibited act under section 301(dd).

Gonzar Produce, LLC must register its facility within 30 working days and respond in writing within 15 working days, detailing corrective actions, including a copy of their FSVP and implementation records. Failure to comply may result in refusal of admission for imported foods under