R.R. Importaciones Inc. – FDA Warning Letter, Aug 21, 2025

The FDA issued a Warning Letter to R.R. Importaciones Inc. following inspections on August 21, 2025, and previously from October 3-5, 2023. The inspections revealed significant violations of the Foreign Supplier Verification Program (FSVP) regulation, outlined in section 805 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR part 1, subpart L. This regulatory framework requires importers to conduct risk-based activities to ensure imported human and animal food meets U.S. food safety standards. The primary issue identified was the company"s failure to develop, maintain, and follow an adequate FSVP for any of the foods it imports, including products like (b)(4) and chocolate from various foreign suppliers. The FDA noted that the company"s prior response to observations lacked sufficient supporting documentation to demonstrate corrective actions. R.R. Importaciones Inc. is required to respond in writing within fifteen working days, detailing specific corrections made to address these violations. The response must include comprehensive documentation, such as a copy of their developed FSVP and records demonstrating its implementation. Failure to adequately address these concerns could lead to further enforcement actions, including the refusal of admission for imported food and placement on detention without physical examination.