FDA WARNING_LETTER - Ocho Rios Atlanta Inc. - September 30, 2025

The FDA issued a Warning Letter to Ocho Rios Atlanta Inc. following an inspection conducted from September 18th to 30th, 2025. The inspection aimed to assess compliance with the Foreign Supplier Verification Program (FSVP) requirements under Section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. The primary violation identified was the company"s failure to develop, maintain, and follow an FSVP for several imported food products, including mixed spices and seasonings, brown sauce, juice drinks, and tea. The FSVP regulation mandates that importers perform risk-based activities to ensure imported human and animal foods meet U.S. food safety standards. Without these programs, Ocho Rios Atlanta Inc. is not in compliance with the FD&C Act. While the company provided a response indicating an intent to develop FSVP plans, it was deemed inadequate due to a lack of specific timeframes and supporting documentation for corrective actions. The FDA requires a written response within fifteen working days detailing concrete steps taken to correct the violations, along with relevant documentation such as copies of new FSVP plans and records demonstrating their implementation. Failure to adequately address these issues may result in further regulatory action, including refusal of admission for imported foods and detention without physical examination.