FDA WARNING_LETTER - Fres Co, LLC - January 24, 2022

The FDA conducted a Foreign Supplier Verification Program (FSVP) inspection of Fres Co, LLC from December 7, 2021, to January 24, 2022, following a previous inspection in 2020. The inspection aimed to assess compliance with section 805 of the FD&C Act and 21 CFR part 1, subpart L, which mandates importers to verify that imported food meets U.S. food safety standards. The FDA found that Fres Co, LLC was not in compliance with these requirements for any of the foods it imports, including fresh plantains, mangoes, and tomatoes. The primary violation identified was the firm's failure to develop, maintain, and follow an FSVP, as required by section 805 of the FD&C Act and 21 CFR part 1.502(a). The company admitted to not developing FSVPs for any imported foods, and documents provided were incomplete or not properly applied to an FSVP program. No response was received to the Form FDA 483a issued. The FDA warned that failure to address these violations could lead to refusal of admission for imported food under section 801(a)(3) of the FD&C Act, potential detention without physical examination (DWPE), and prohibition of importation under section 301(zz). Fres Co, LLC is required to respond in writing within fifteen working days, detailing corrective actions and providing supporting documentation, such as copies of developed and implemented FSVPs.