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ISPE Produce, Inc., an importer of fresh produce including Roma tomatoes, bell peppers, and lettuce, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by FDA regulations. During inspections conducted in July 2023 and February 2024, the FDA found that the company had not established any FSVP for the foods it imported, representing a significant violation of section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1, subpart L. The company did not respond to the FDA's Form 483a observations issued on February 29, 2024, compounding the compliance failure.