FDA WARNING_LETTER - Mexpobaja Corporation - August 31, 2023

The FDA issued a Warning Letter to Mexpobaja Corporation following a Foreign Supplier Verification Program (FSVP) inspection from August 29-31, 2023, with previous inspections in 2022 and 2021. The inspection revealed significant violations of the FSVP regulation (21 CFR part 1, subpart L) and Section 805 of the FD&C Act.

Mexpobaja Corporation failed to develop, maintain, and follow an FSVP for several imported foods. While some FSVP documents were provided for specific foods like Pitahaya (Dragonfruit), Pasilla Peppers (Poblano), and Jalapeno Peppers, they did not meet requirements. Specifically, supplier verification activities did not adequately assure that biological hazards in covered produce were significantly minimized or prevented, as required by 21 CFR 1.506(c). The company did not verify supplier compliance with the Produce Safety Rule (21 CFR part 112) or demonstrate that alternative processes provided an equivalent level of public health protection. Records of onsite audits were not provided, and letters of guarantee or food safety questionnaires lacked sufficient detail regarding compliance standards.

The FDA noted that the company did not provide details or data to support claims of equivalent public health protection. The letter also highlighted requirements for importers of food from very small farms. Failure to address these violations may result in refusal of admission for imported foods under Section 80