FDA WARNING_LETTER - Concord Farms, Inc. - August 03, 2021

On July 20-August 3, 2021, the FDA inspected Concord Farms, Inc. in Vernon, CA, for compliance with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L). This inspection was prompted by a June 29, 2021, voluntary recall of fresh enoki mushrooms imported from a Korean supplier, which tested positive for *Listeria monocytogenes*.

The inspection revealed significant FSVP violations for imported fresh enoki mushrooms from two Korean suppliers and oyster mushrooms from another supplier, as well as other foods. Concord Farms failed to develop, maintain, and follow an FSVP for these foods (21 CFR 1.502(a)). They did not conduct a written hazard analysis or document their review and assessment of a foreign supplier's hazard analysis (21 CFR 1.504(a), (d)).

Furthermore, Concord Farms did not approve foreign suppliers based on performance and food risk, failing to consider supplier procedures related to food safety or compliance with FDA regulations like the Produce Safety Rule (21 CFR Part 112) for raw agricultural commodities (21 CFR 1.505(a)). Their supplier verification activities, such as "Safety record review" and "SAHCODHA Haz (yearly onsight audit)," did not adequately assure that hazards were minimized or prevented, nor did they verify compliance with the Produce