FDA WARNING_LETTER - Best Fiji Kava, Inc. - November 16, 2021

On February 16, 2022, the FDA issued a Warning Letter to Best Fiji Kava, Inc. following a Foreign Supplier Verification Program (FSVP) inspection on November 16, 2021, and a previous inspection on July 10, 2019. The inspection found the firm 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, specifically citing products from a supplier in (b)(4). The firm was issued a Form FDA 483a, FSVP Observations, on November 16, 2021, but no response has been received. Although the firm stated an intent to retain a consultant, no information regarding FSVPs or corrective actions has been provided.

Failure to adequately 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 301(zz) of the FD&C Act. The firm must respond in writing within fifteen working days, detailing