FDA WARNING_LETTER - SOHGAVE LLC - October 28, 2022

On January 19, 2023, the FDA issued a Warning Letter to Sohgave LLC following Foreign Supplier Verification Program (FSVP) inspections conducted from October 24-28, 2022, and previously from August 26-September 13, 2021. The inspections aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandate importers perform risk-based activities to verify imported food meets U.S. safety standards.

The FDA found Sohgave LLC not in compliance, specifically citing a significant violation: the company failed to develop, maintain, and follow an FSVP for any imported foods, including honey and agave syrup, as required by 21 CFR 1.502(a). The company admitted to not having an FSVP and provided certificates of analysis that were not associated with an FSVP.

Sohgave LLC's November 8, 2022, email response, stating an intent to complete the FSVP by November 30, 2022, was deemed inadequate due to a lack of documentation demonstrating corrective actions.

Failure to address these violations may lead to further FDA action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE) under Import