FDA WARNING_LETTER - Jerez Produce, Inc. - February 28, 2023

On April 11, 2023, the FDA issued a Warning Letter to Jerez Produce, Inc. following Foreign Supplier Verification Program (FSVP) inspections conducted from February 2-28, 2023, and previously on August 26, 2021. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. food safety standards.

The FDA found Jerez Produce, Inc. was not in compliance with FSVP requirements for imported foods. Specifically, the company failed to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods, including covered produce. As an importer of covered produce, the firm must ensure its supplier's production processes provide public health protection equivalent to 21 CFR part 112.

Although the firm may qualify as a "very small importer" under 21 CFR 1.500, requiring modified compliance under 21 CFR 1.512, it still failed to meet the basic requirements of 21 CFR 1.502, 1.503, and 1.509. The company also did not obtain required written assurances from foreign suppliers every two years, as