JUQUILITA MEXICAN IMPORTS LLC – FDA Warning Letter, Feb 2, 2024

On March 25, 2024, the FDA issued a Warning Letter to Juquilita Mexican Imports LLC following a Foreign Supplier Verification Program (FSVP) inspection on February 2, 2024, and a prior inspection on December 14, 2022. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L.

The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). Although the firm indicated it might qualify as a "very small importer" under 21 CFR 1.512, it failed to document this status (21 CFR 1.512(b)(1)(i)) and did not obtain required written assurances from foreign suppliers regarding compliance with U.S. food safety standards (21 CFR 1.512(b)(3)(i)).

The FDA investigator issued a Form FDA 483a on February 2, 2024, to which no response was received. Failure to adequately address these violations may result in refusal of admission for imported foods under section 801(a)(3) of the FD&C Act, placement on detention without physical examination (Import Alert # 99-