FDA WARNING_LETTER - Zip Foods Importers, Inc - June 27, 2025

The Food and Drug Administration (FDA) issued a Warning Letter to Zip Foods Importers, Inc. on January 16, 2026, following inspections conducted from November 18-22, 2024, and June 20-27, 2025. These inspections revealed significant non-compliance with the Foreign Supplier Verification Program (FSVP) regulation, which is based on section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. This regulatory framework requires importers to verify that foreign-produced human and animal food meets U.S. food safety standards.

The primary violation involved Zip Foods Importers, Inc."s failure to develop, maintain, and adhere to an FSVP for numerous imported food products. These included Millet Seed, Buckwheat, various mushroom products, Cherry Fruit, Mixed Fruit, Frozen Black Currants, Baked Snack Food, Granola Bars, Plain Cookies, Biscuits, Cheesecake, Cheese Sticks, and Smoked Cheese Sticks. The company"s previous responses were deemed inadequate as they did not provide supporting documentation for corrective actions related to the listed foods.

To address these serious violations, Zip Foods Importers, Inc. is required to submit a written response within fifteen working days. This response must detail specific corrective actions and include comprehensive documentation demonstrating compliance, such as updated FSVP records and evidence of their implementation. Failure to adequately resolve these issues could result in severe consequences, including the refusal of admission for imported foods, detention without physical examination, and legal prohibition under section 301(zz) of the FD&C Act.