FDA WARNING_LETTER - Mexia Pallets LLC - April 07, 2022

On August 16, 2022, the FDA issued a Warning Letter to Mexia Pallets LLC following Foreign Supplier Verification Program (FSVP) inspections conducted from April 5-7, 2022, and August 3-12, 2021. The inspections revealed significant violations of section 805 of the FD&C Act and 21 CFR part 1, subpart L, as the company failed to develop, maintain, and follow an FSVP for imported food products, including fresh produce (Persian Limes), Apple Soft Drink, and Orange Soft Drink.

The company's April 13, 2022, response, requesting three months to gather information, was deemed inadequate as it lacked evidence of corrective steps. A subsequent email from FDA on May 13, 2022, received only entry documents. No response was provided for observations from the August 2021 inspection.

The FDA noted that if Mexia Pallets LLC qualifies as a "very small importer," it must still comply with FSVP requirements, including annual documentation of this status and obtaining written assurances from foreign suppliers every two years regarding compliance with U.S. food safety standards. For imported "covered produce" like Persian Limes, the FSVP must demonstrate compliance with 21 CFR part 112 (Produce Safety Rule).

Additionally, the company failed to provide a valid