FDA WARNING_LETTER - Moises Gardea - March 24, 2023

The FDA issued a Warning Letter to Moises Gardea following a Foreign Supplier Verification Program (FSVP) inspection conducted from March 9-24, 2023, with a previous inspection from July 20-30, 2021. The inspection found the importer 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 significant violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR 1.502(a). A Form FDA 483a FSVP Observations was issued on March 24, 2023, to which no response has been received.

Failure to address these violations may result in further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act and potential detention without physical examination (DWPE) under Import Alert #99-41. Importing food without a compliant FSVP is prohibited under section 301(zz) of the FD&C Act.

The FDA noted that Moises Gardea might qualify as a "very small importer" under 21 CFR 1.500, which offers modified FSVP