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Del Valle Import Corp. failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for imported fresh produce including dragon fruit, sweet melons, and fresh plantains, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. During inspections conducted in July-August 2022 (and previously in 2021), FDA investigators identified that the company had not implemented any FSVP for the foods it imported, despite the regulatory requirement for importers to perform risk-based verification activities to ensure imported foods meet U.S. food safety standards. The company did not respond to the FDA Form 483a observations issued on August 17, 2022, documenting these significant violations.