DELIIMPORTS, LLC Warning Letter Details

Summary

DELIIMPORTS, LLC, a food and beverage importer based in McAllen, Texas, failed to establish and maintain a Foreign Supplier Verification Program (FSVP) as required by FDA regulations, despite importing multiple food products into the United States. During a September 2022 FDA inspection, investigators found that the company had not developed any FSVP documentation for the foods it imported and did not respond to the FDA 483a observations issued at the conclusion of the inspection. These violations represented significant non-compliance with section 805 of the Federal Food, Drug and Cosmetic Act and 21 CFR part 1, subpart L, which mandate that importers perform risk-based verification activities to ensure imported foods meet U.S. food safety standards.