FDA WARNING_LETTER - Cavevi Naturals LLC - August 09, 2023

On November 8, 2023, the FDA issued a Warning Letter to Cavevi Naturals LLC, following a Foreign Supplier Verification Program (FSVP) inspection conducted from August 4-9, 2023, at their Edinburg, TX location. A previous inspection occurred on December 16, 2020. The inspection found the company non-compliant with 21 CFR part 1, subpart L, and section 805 of the FD&C Act, which requires importers to perform risk-based activities to verify imported food meets U.S. food safety standards.

The primary violation identified was the failure to develop, maintain, and follow an FSVP for any imported foods, as required by 21 CFR part 1.502(a). The company received a Form FDA 483a, FSVP Observations, at the inspection's conclusion. Their August 31, 2023, response, stating intent to hire a consultant to develop an FSVP within four months, was deemed inadequate due to a lack of supporting documentation or copies of implemented FSVPs.

Failure to address these violations 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 30