Concord Farms, Inc. Warning Letter Details

Summary

Concord Farms, Inc., an importer of fresh mushroom products, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under 21 CFR part 1, subpart L during an FDA inspection conducted July-August 2021. The inspection was triggered by a recall of fresh enoki mushrooms imported from Korea that tested positive for Listeria monocytogenes, which the company had voluntarily recalled in June 2021. The FDA found that Concord Farms did not perform adequate risk-based verification activities to ensure that imported fresh enoki mushrooms, oyster mushrooms, and other products from multiple foreign suppliers met applicable U.S. food safety standards.