Eli’s Manhattan Warehouse, Inc. Warning Letter Details

Summary

Eli's Manhattan Warehouse, Inc., a food and beverage importer, failed to comply with Foreign Supplier Verification Program (FSVP) requirements under 21 CFR Part 1 Subpart L during FDA inspections conducted in August-September 2021 and previously in December 2018. The company did not perform adequate risk-based verification activities to ensure imported foods met applicable U.S. food safety standards, and submitted incomplete documentation including hazard analyses and preventive controls in languages other than English and an unidentified training certificate. These violations represented significant non-compliance with Section 805 of the Federal Food, Drug, and Cosmetic Act, which requires importers to verify their foreign suppliers' compliance with U.S. food safety standards.