FDA WARNING_LETTER - Bolive, Inc. - February 22, 2022

On February 22, 2022, the FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Bolive, Inc. in Upland, CA, to assess compliance with 21 CFR part 1 subpart L and section 805 of the FD&C Act. The inspection revealed Bolive, Inc. was not in compliance with FSVP requirements for foods imported from various foreign suppliers, including specific halva, tahini, and black olives.

The primary violation identified was the failure to develop, maintain, and follow an FSVP as required by 21 CFR part 1.502(a). Bolive, Inc. acknowledged not having an FSVP plan and requested six weeks to develop one, claiming eligibility for modified FSVP requirements as a very small importer based on sales. However, the company did not provide supporting documentation to substantiate its "very small importer" status, nor did it submit any FSVP records. Even if classified as a very small importer, Bolive, Inc. is still required to comply with certain FSVP provisions, including documenting its status annually and obtaining written assurances from foreign suppliers regarding compliance with U.S. food safety standards.

The FDA stated that failure to adequately address these violations could lead to further action, including refusal of admission for imported food under section 801(a)(3) of the FD&C Act and placement on detention without physical examination (DWPE) via