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RNA Bio/Pharma, Incorporated failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, specifically for oral liquid homeopathic drug products including those intended for children. During an April 2025 inspection, the FDA found that the company did not adequately test components for purity, strength, quality, and identity, and failed to validate the reliability of its component suppliers' test analyses at appropriate intervals, instead relying solely on suppliers' certificates of analysis without verification. The company also failed to respond to the FDA's Form FDA 483 inspectional observations despite two Agency inquiries, compounding the enforcement action.