FDA WARNING_LETTER - Lemond Trading Corp - November 26, 2019

The FDA issued a Warning Letter to Lemond Trading Corp. following inspections on November 25-26, 2019, and July 24, 2018, at their Honolulu facility. The inspections revealed significant violations of the Foreign Supplier Verification Program (FSVP) requirements under section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1 subpart L. Specifically, the firm failed to develop FSVPs for any of the food products they import, including items like red pepper powder, frozen noodles, and assorted dumplings. This indicates a fundamental failure to perform risk-based activities to verify that imported foods meet U.S. food safety standards. The company's November 27, 2019, response, which stated an intent to appoint someone to develop an FSVP, was deemed inadequate due to a lack of specific details or timeframes for implementation. The FDA requires prompt corrective action, including the development and implementation of comprehensive FSVPs for all imported foods. Failure to comply could result in severe business implications, such as refusal of admission for imported products, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation. A written response detailing corrective actions and supporting documentation is required within fifteen working days.