FDA WARNING_LETTER - Las Americas Supermercado#2 Inc. - September 08, 2025

The FDA issued a Warning Letter to Las Americas Supermercado#2 Inc. following an inspection conducted from August 28 to September 8, 2025. The inspection revealed significant violations related to the company's import practices, specifically its failure to develop, maintain, and follow a Foreign Supplier Verification Program (FSVP) for foods imported into the United States. This includes products such as cabbage, green prickly pear, and fresh cilantro.

This non-compliance violates Section 805 of the Federal Food, Drug, and Cosmetic Act and the implementing FSVP regulation (21 CFR part 1, subpart L), which mandates importers to verify that foreign-produced foods meet U.S. food safety standards. The FDA noted that the company's initial response lacked supporting documentation for its stated corrective actions, rendering it insufficient.

Las Americas Supermercado#2 Inc. is required to respond in writing within 15 working days. This response must detail concrete corrective measures taken and include comprehensive documentation, such as a copy of their developed FSVP and records demonstrating its implementation. Failure to adequately address these issues could result in severe consequences, including refusal of admission for imported foods, detention without physical examination, and legal prohibitions on future imports.