MKK Imports Warning Letter Details

Summary

MKK Imports, a food and beverage importer based in California, failed to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for multiple imported food products including Orange Fruit Jelly, Fried Potato Chips, and Baked Wheat Cracker, in violation of Section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 1, Subpart L. During a March 2023 inspection, the FDA identified these significant compliance failures and issued a Form FDA 483a, to which the company did not respond. The company's inability to implement required risk-based verification activities to ensure imported foods meet applicable U.S. food safety standards represented a material breach of FSVP obligations.