FDA WARNING_LETTER - Delicias Del Contry Usa Inc - March 24, 2025

The Food and Drug Administration (FDA) issued a Warning Letter to Delicias Del Country USA Inc, following inspections conducted from March 10-24, 2025, and previously from March 10-22, 2023. The primary issue identified was the company"s significant non-compliance with the Foreign Supplier Verification Program (FSVP) regulation, outlined in section 805 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 1, subpart L. This regulatory framework mandates importers to perform risk-based activities to ensure imported foods meet U.S. food safety standards.

Delicias Del Country USA Inc failed to develop, maintain, and follow an FSVP for any of its imported food products, specifically listing Turtle Pie, Strawberry and Pecan Cake, and Pineapple Pastry. The FDA acknowledged the company"s response dated March 24, 2025, stating plans for FSVP training and program implementation within 6-8 months, but found it inadequate due to a lack of supporting documentation.

The FDA requires Delicias Del Country USA Inc to respond in writing within fifteen working days, detailing specific corrective actions and providing supporting documentation, such as a copy of its FSVP and records demonstrating its implementation. Failure to adequately address these violations may result in further FDA action, including refusing admission of imported food or placing products on detention without physical examination.