Martinez Mexican Produce Llc – FDA Warning Letter, Mar 6, 2020

On June 16, 2020, the FDA issued a Warning Letter to Martinez Mexican Produce, LLC, following a Foreign Supplier Verification Program (FSVP) inspection on March 6, 2020, and a previous inspection on February 15, 2018. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1 subpart L, which mandates importers to conduct risk-based activities to verify imported food meets U.S. food safety standards.

The firm was found non-compliant for mayonnaise imported from (b)(4) and shredded coconut imported from (b)(4), as they failed to develop, maintain, and follow an FSVP for these products, violating 21 CFR 1.502(a). Form FDA 483a, FSVP Observations, was issued after both inspections, but no response was received.

Failure to correct these significant violations may lead to refusal of admission for the implicated products under section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE) for all foods from their foreign suppliers (Import Alert # 99-41). Importing food without a compliant FSVP is also prohibited under section 301(zz) of the FD&C Act.

Martinez Mexican Produce, LLC, must respond in writing within fifteen working days