FDA 483 - RNA Coporation - December 19, 2025

RNA Corporation, a contract manufacturer in Blue Island, IL, received a Form 483 citing significant deficiencies in its quality control unit, particularly concerning electronic record audit trails and analytical raw data review. The inspection revealed a failure to follow established SOPs, a lack of raw data reviews, and untrained personnel for critical data integrity tasks. These issues indicate a systemic breakdown in data management and quality assurance processes.