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Molino Enterprises One, Inc., a food importer in Bronx, NY, failed to comply with the Foreign Supplier Verification Program (FSVP) regulation for whole wheat breadsticks and other products imported from a foreign supplier. The company did not develop, maintain, and follow an FSVP as required by section 805 of the Federal Food, Drug and Cosmetic Act, despite a prior inspection in April 2019 and an FDA Form 483a issued at the conclusion of the August-September 2021 inspection. The company had not responded to the FDA's observations as of the warning letter issuance in January 2022.