FDA WARNING_LETTER - VARGAS PRODUCE LLC - June 18, 2026

The U.S. Food and Drug Administration (FDA) issued a formal warning letter to Vargas Produce LLC, a McAllen, Texas-based importer, following inspections conducted in February 2025 and June 2026. These inspections were carried out to evaluate the company’s adherence to the Foreign Supplier Verification Program (FSVP) regulations, which are mandated by the Federal Food, Drug, and Cosmetic Act. These safety standards require importers to perform risk-based activities to ensure that food produced abroad and brought into the United States meets the same safety and health requirements as domestic products. The FDA’s investigation determined that Vargas Produce LLC failed to develop, maintain, or follow an FSVP for several of its imported products, specifically citing cookies, soft drinks, and spicy potato chips. Because the company did not have these required safety verification programs in place, they were unable to demonstrate that their foreign suppliers were following appropriate food safety protocols. The FDA warned that failure to address these violations promptly could lead to serious consequences, such as the agency refusing to allow the company"s products into the country or placing them on a detention list. Vargas Produce LLC is required to provide a written response within 15 working days. This response must include documentation of the corrective actions taken, such as copies of newly established verification programs and records showing their implementation. If the company cannot complete these corrections immediately, they must provide a reason for the delay and a specific timeline for when they will be in full compliance.