FDA WARNING_LETTER - PASO REAL PRODUCE LLC - August 14, 2024

On October 1, 2024, the FDA issued a Warning Letter to Paso Real Produce, LLC, following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 9-14, 2024, at their Pharr, TX location. Previous inspections occurred on September 10, 2021, and April 4-5, 2023. The inspection found the company non-compliant with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, a repeat observation from prior inspections. The company did not respond to the Form FDA 483a FSVP Observations issued on August 14, 2024.

Failure to address this violation may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, potentially leading to detention without physical examination (DWPE) as per Import Alert #99-41. Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

Paso Real Produce, LLC must respond in writing within fifteen working days, detailing corrective actions