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Lempira Distribution LLC, a food and beverage importer in Miami, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation (21 CFR part 1, subpart L) required to verify that imported foods meet U.S. safety standards. During inspections conducted in June-July 2021 and previously in December 2017, the FDA found the company had not established adequate FSVP documentation for its products and did not provide sufficient details or copies of FSVPs despite claiming to be developing them. The company's failure to implement a compliant FSVP program for each product represented a significant violation of section 805 of the Federal Food, Drug, and Cosmetic Act.