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Mr Lukas LLC, a food importer based in McAllen, Texas, failed to develop and implement Foreign Supplier Verification Programs (FSVPs) for imported food products including canned nacho sliced jalapenos, Mexican style hominy, and tomato tomatillo, in violation of Section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1 subpart L. The FDA conducted inspections on August 29, 2018, and January 25-28, 2021, documenting these compliance failures and issuing Form FDA 483a observations both times, to which the company provided no response. The importer's lack of risk-based verification procedures meant it could not demonstrate that the imported foods met applicable U.S. food safety standards.