FDA WARNING_LETTER - Balkanica LLC - May 20, 2026

Balkanica LLC, based in Clifton, New Jersey, was issued a formal Warning Letter by the U.S. Food and Drug Administration (FDA) on June 29, 2026. This action followed inspections conducted on July 31, 2023, October 24, 2024, and May 20, 2026, which aimed to evaluate the company’s compliance with the Foreign Supplier Verification Program (FSVP) regulations. These regulations, part of the Federal Food, Drug, and Cosmetic Act, require importers to verify that foreign food suppliers meet U.S. safety standards. The FDA’s investigation revealed that Balkanica LLC failed to develop and implement required verification programs for several imported products, specifically Sunflower Seeds from Iadki Detelina Ltd. and Sheep’s Milk Cheese from Makler Komers LTD, both located in Bulgaria. Although the company indicated it had hired a qualified individual to begin organizing its compliance documents, the FDA deemed this response insufficient because the company failed to provide actual evidence of completed safety evaluations or program implementation. To address these violations, Balkanica LLC is required to submit a written response within 15 working days. This response must include specific documentation, such as completed FSVP records, to prove that corrective actions have been fully implemented. Failure to satisfy these requirements could result in the FDA refusing entry of the company’s imports into the United States or placing the products on a detention list, which allows for seizure without physical examination.