A TO Z DISTRIBUTOR INC – FDA Warning Letter, Sep 17, 2025

The FDA issued a Warning Letter to A TO Z Distributor Inc. on February 10, 2026, citing significant violations of food safety regulations. Inspections were conducted on September 17, 2025, with prior visits on July 14, 2021, and February 20, 2025, focusing on the company"s Foreign Supplier Verification Program (FSVP). The main violation identified was the company"s failure to establish, maintain, and adhere to an FSVP for several imported food items, including Cucumbers In Brine, Original, Roasted Sesame Seeds, and Spread. This omission signifies a non-compliance with section 805 of the Federal Food, Drug, and Cosmetic Act and its implementing FSVP regulation (21 CFR part 1, subpart L), which mandates importers to verify that foreign suppliers meet U.S. food safety standards. A TO Z Distributor Inc. must respond within fifteen working days, detailing corrective actions and providing supporting documentation, such as a copy of their developed FSVP and implementation records. Additionally, the company is required to register its facility with the FDA within 30 working days. Non-compliance may lead to severe consequences, including the refusal of admission for imported products into the United States and placement on detention without physical examination.