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Productos Bredy USA LLC, a food and beverage importer based in Houston, Texas, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for any of its imported products, including soft drinks from a foreign supplier, in violation of Section 805 of the Federal Food, Drug, and Cosmetic Act. Despite registering for FSVP training and committing to develop the program following an initial inspection in September 2018, the company had not created an FSVP for any imported products by the time of the March 2021 reinspection and did not respond to the FDA 483a observations issued at the conclusion of that inspection. The company's failure to implement risk-based supplier verification activities meant its imported foods could not be verified as meeting applicable U.S. food safety standards.