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Kuzmir Imports Inc. failed to comply with Foreign Supplier Verification Program (FSVP) requirements for imported food products including mini soup croutons, nougat spread, and cashews. The company did not conduct required hazard analyses for the foods it imported to determine whether hazards required controls, as mandated by 21 CFR 1.504(a). The FDA conducted inspections in March 2022 and issued a Form FDA 483a with observations, to which the company had not responded by the time the warning letter was issued. This represented a significant violation of section 805 of the Federal Food, Drug, and Cosmetic Act.