FDA WARNING_LETTER - Greenfruit Avocados, LLC - January 18, 2024

On July 8, 2024, the FDA issued a Warning Letter to Greenfruit Avocados LLC following a Foreign Supplier Verification Program (FSVP) inspection from January 16-18, 2024, and previous inspections in 2020 and 2023. The inspection found the company non-compliant with 21 CFR part 1, subpart L, for imported (b)(4) Avocados, violating section 805 of the FD&C Act.

The primary violations include: 1. **Failure to approve foreign suppliers based on performance and risk (21 CFR 1.505(b)):** Greenfruit Avocados LLC did not evaluate the growers of avocados, who are the true "foreign suppliers" as defined by 21 CFR 1.500, considering packers as suppliers instead. The company did not assess growers' compliance with the Produce Safety Rule (21 CFR Part 112) for biological hazards. Submitted documentation focused on post-harvest operations of packers, not the growers. 2. **Failure to establish and follow written procedures for importing from approved suppliers (21 CFR 1.506(a)(1)):** The company lacked written procedures to ensure imports only from approved foreign suppliers (growers). While procedures for evaluating packers existed, they were not applied to the actual foreign suppliers (growers).