Nature’s Way Farms, LLC Warning Letter Details

Summary

Nature's Way Farms, LLC, a food importer based in Texas, failed to comply with the Foreign Supplier Verification Program (FSVP) requirements mandated under section 805 of the Federal Food, Drug, and Cosmetic Act. During inspections conducted in June-July 2022 (following a prior inspection in October 2020), the FDA identified significant violations of 21 CFR part 1, subpart L for foods imported from foreign suppliers, including the company's failure to perform required risk-based verification activities to ensure imported foods met applicable U.S. food safety standards. Although the company responded to FDA observations on July 17, 2022, claiming a consultant would develop corrective actions by September 1, 2022, no supporting documentation of planned or completed corrective actions was subsequently provided to the FDA.