Baja Best Distributing, Inc. – FDA Warning Letter, Feb 23, 2024

On May 1, 2024, the FDA issued a Warning Letter to Baja Best Distributing, Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted on February 23, 2024, and previously from June 8-28, 2023. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1, Subpart L, which mandates risk-based activities for importers to verify foreign food safety standards.

The FDA found significant violations, specifically that Baja Best Distributing, Inc. failed to develop, maintain, and follow an FSVP for any imported foods, including fresh produce classified as "covered produce." This violates 21 CFR 1.502(a) and Section 805 of the FD&C Act, as the firm did not demonstrate that its suppliers meet U.S. food safety standards, including those under 21 CFR Part 112 (Standards for Produce Safety).

The FDA acknowledged the firm's March 14, 2024, response requesting a five-month extension to develop FSVP plans but deemed it inadequate due to a lack of supporting documentation or details on corrective actions.

Failure to address these violations may result in refusal of admission for imported food products under Section 801(a)(3) of the FD&C Act, placement on detention