FDA WARNING_LETTER - MR LUKAS LLC - January 28, 2021

The FDA issued a Warning Letter to Mr. Barrera following Foreign Supplier Verification Program (FSVP) inspections conducted on January 25-28, 2021, and previously on August 29, 2018. The inspections aimed to assess compliance with Section 805 of the FD&C Act and 21 CFR Part 1 subpart L for imported foods, including canned nacho sliced jalapenos, Mexican style hominy, and tomato tomatillo. The primary violation identified was the firm's failure to develop FSVPs for these imported products, as required by 21 CFR 1.502(a). This deficiency means the firm has not performed the necessary risk-based activities to verify that its imported foods meet U.S. food safety standards. Despite receiving Form FDA 483a observations after both inspections, the FDA has not received any response from the firm. The Warning Letter emphasizes that the firm remains the FSVP importer and must comply with all requirements. The FDA requires a written response within fifteen working days detailing corrective actions, including documentation of developed and implemented FSVPs. Failure to adequately address these violations could lead to severe consequences, such as refusal of admission for imported products, detention without physical examination (DWPE) under Import Alert #99-41, and prohibition of importation under section 301(zz) of the FD&C Act.