FDA WARNING_LETTER - Mercado Hispano Distributors, LLC - March 23, 2022

On August 2, 2022, the FDA issued a Warning Letter to Mercado Hispano Distributors, LLC, following a Foreign Supplier Verification Program (FSVP) inspection from February 23 to March 23, 2022. This was the third inspection, with previous ones on March 22, 2018, and November 3 to December 18, 2020. The firm was found non-compliant with section 805 of the FD&C Act and 21 CFR part 1, subpart L, for imported foods.

The primary violation cited was the failure to develop, maintain, and follow an FSVP as required by 21 CFR 1.502(a) for any imported foods. Despite a May 9, 2022, response acknowledging online FSVP training registration, the firm provided no documentation of compliance activities, marking the third inspection without FSVP records.

The FDA requires prompt corrective action. Failure to comply may result in refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz). The firm must respond in writing within fifteen working days, detailing corrective actions, providing FSVP documentation, and explaining any delays.