FDA 483 - R.R. Importaciones Inc. - October 05, 2023

During an inspection conducted from October 3-5, 2023, the U.S. Food and Drug Administration (FDA) issued a Form FDA 483a to R.R. Importaciones Inc. of Passaic, NJ. The inspection focused on the company's adherence to the Foreign Supplier Verification Program (FSVP) requirements, established under Section 805 of the Federal Food, Drug and Cosmetic Act. The primary observation noted was that R.R. Importaciones Inc. failed to develop an FSVP for all foods imported between October 1, 2022, and September 30, 2023. Specifically, the company's president, Rogelio Martinez, confirmed the absence of an FSVP for numerous imported food products and their associated suppliers, as detailed in an attachment to the report. This indicates a significant oversight in ensuring the safety and compliance of foreign-sourced food items. To address this observation, R.R. Importaciones Inc. is required to establish and implement a comprehensive FSVP that meets regulatory standards for all relevant imported foods. The FDA emphasizes that these are observations, not a final determination of compliance, and the company has the opportunity to respond with corrective actions.