Regino Produce LLC Warning Letter Details

Summary

Regino Produce LLC, an importer of food products including fried corn chips, fresh serrano peppers, and fresh lettuce, failed to establish Foreign Supplier Verification Programs (FSVPs) for these imported items and most other foods it imported, in violation of section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. During FDA inspections on April 5 and 11, 2022, investigators found the company had no documented FSVPs or risk-based verification activities to ensure its imported products met U.S. food safety standards. Although the company requested four additional months to develop FSVPs in its April 26, 2022 response, the FDA determined the response was inadequate as it lacked written procedures or documentation demonstrating corrective action.