FDA WARNING_LETTER - SAN JORGE PRODUCE LLC - June 10, 2026

The FDA issued a warning letter to San Jorge Produce LLC following an inspection conducted from June 1 to June 10, 2026, at its McAllen, Texas, facility. This follow-up inspection revealed that the company remains out of compliance with the Foreign Supplier Verification Program (FSVP) requirements established under the Federal Food, Drug, and Cosmetic Act. These regulations mandate that U.S. importers verify their foreign suppliers produce food using safety standards equivalent to those required in the United States. The primary violation is the company’s failure to develop and implement an FSVP for various imported items, including bananas, jackfruit, jicama, limes, and plantains from several foreign sources. Because these items are considered fresh produce, the company must specifically demonstrate that its suppliers adhere to safety processes that protect public health. The FDA has directed San Jorge Produce LLC to submit a written response within 15 working days outlining the corrective actions taken to address these deficiencies. This response must include supporting documentation, such as copies of the newly established verification programs and records of their implementation. The FDA warned that failure to correct these issues promptly may lead to more severe consequences, including the refusal of entry for their imported products into the United States and the placement of those goods on an import detention list.