Mena Produce LLC – FDA Warning Letter, Jun 21, 2022

On September 20, 2022, the FDA issued a Warning Letter to Mena Produce LLC following a Foreign Supplier Verification Program (FSVP) inspection conducted from June 14-21, 2022, and a previous inspection in October 2020. 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 primary violation was the failure to develop, maintain, and follow an FSVP for any imported foods, including Anaheim, Tomatillo, and Poblano Peppers, which are "covered produce" under 21 CFR 112.3. This means the company did not demonstrate that its suppliers produce food in compliance with public health protection standards equivalent to those required under Section 419 of the FD&C Act and 21 CFR part 112 (Produce Safety Rule).

Mena Produce's July 15, 2022, response stated they had not developed an FSVP due to focusing on facility certification and had hired a consultant, estimating 3-4 months for current products and 9-12 months for all imported foods. However, the FDA found the response inadequate due to a lack of specific steps or records.

Failure to address these violations