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San-Rey Produce Inc., an importer of food and beverages, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation required under Section 805 of the Federal Food, Drug, and Cosmetic Act. During inspections conducted in August and November 2022, the FDA found that the company did not develop, maintain, or follow an FSVP for any of the foods it imported into the United States. The company's response to the FDA's initial observations lacked supporting documentation or description of specific corrective steps taken to address the violations. This represented a significant failure to implement the risk-based verification activities necessary to ensure imported foods met applicable U.S. food safety standards.