FDA WARNING_LETTER - ECO FOOD DISTRIBUTION, LLC - March 29, 2023

On February 28 through March 29, 2023, the FDA conducted an inspection of Eco Food Distribution, LLC, for compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1 subpart L). This was the third inspection since July 2019. The inspection revealed significant violations, indicating non-compliance with section 805 of the FD&C Act.

Key violations include: 1. Failure to develop, maintain, and follow an FSVP for imported foods (21 CFR 1.502(a)). 2. Failure to conduct a written hazard analysis for imported chocolate-covered gingerbread apple and carrot nectar (21 CFR 1.504). 3. Failure to approve foreign suppliers based on performance and risk evaluation, and to document approval, specifically for the chocolate-covered gingerbread apple and carrot nectar suppliers (21 CFR 1.505(a), 1.505(b)). 4. Failure to perform and document foreign supplier verification activities, including determining appropriate activities and frequencies, and conducting required activities for the chocolate-covered gingerbread apple and carrot nectar (21 CFR 1.506).

The FDA noted that while the company had an "FSVP Protocol" and some supplier documents (e.g., process flow chart, ISO 22000:2018 certificate),