FDA WARNING_LETTER - Ebenezer International Food, LLC - May 05, 2021

On August 30, 2021, the FDA issued a Warning Letter to Ebenezer International Food, LLC following a Foreign Supplier Verification Program (FSVP) inspection on May 5, 2021, and a previous inspection on February 5, 2020. The inspection found the company non-compliant with Section 805 of the Federal Food, Drug, and Cosmetic Act (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 primary violation was the failure to develop, maintain, and follow an FSVP for imported foods, specifically grounded cassava leaves from (b)(4), and cut sweet potato leaves and cut sorrel leaves from (b)(4). The company did not respond to the Form FDA 483a issued on May 5, 2021.

The FDA noted that grounded cassava leaves from (b)(4) are subject to Detention Without Physical Examination (DWPE) due to Salmonella contamination (Import Alert #99-19), and sorrel leaves from (b)(4) are subject to DWPE due to illegal pesticides (Import Alert #99-08).

The letter also advised that if the company qualifies as a "very small importer," it must document this status and obtain written assurances from foreign suppliers regarding compliance with U