FVD Produce, LLC Warning Letter Details

Summary

FVD Produce, LLC, an importer of fresh produce including tomatoes, husk tomatoes, carrots, and onions, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) as required by Section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart L. During inspections conducted in February-March 2023 and a prior inspection in May 2021, the FDA found that the company did not establish any FSVP for the foods it imported, and documents provided during inspection were deemed insufficient to demonstrate compliance. The company did not respond to the FDA Form 483a issued on March 9, 2023, documenting these observations.