Loading…
Fres Co, LLC, a food importer based in the Bronx, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) for any of its imported foods, including fresh plantains, fresh mangoes, and tomatoes, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. The company did not develop required risk-based verification activities to ensure that imported foods met applicable U.S. food safety standards. The FDA conducted inspections from December 2021 through January 2022 and previously in 2020, finding these significant compliance failures, and the company failed to respond to the Form FDA 483a observations issued on January 24, 2022.