FDA WARNING_LETTER - RNA Bio/Pharma, Incorporated - April 11, 2025

The FDA issued a Warning Letter to RNA Bio/Pharma, Incorporated, following an inspection from April 9 to April 11, 2025, at their Chelan, Washington facility. The letter outlines significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211), leading to the conclusion that their drug products are adulterated. The firm had not responded to the initial inspection observations.

Key violations include a systemic failure to adequately test incoming drug components for identity, purity, strength, and quality, and an over-reliance on supplier Certificates of Analysis without validating their reliability. Specifically, the FDA cited the lack of testing for hazardous contaminants like Diethylene Glycol (DEG) and Ethylene Glycol (EG) in high-risk ingredients such as glycerin, and for impurities like methanol and benzene in ethanol, all of which have been linked to severe poisoning incidents globally. Additionally, the company failed to test potentially toxic ingredients such as strychnine, and neglected to perform testing on homeopathic mother tinctures. These deficiencies raise serious concerns about the safety and quality of their oral liquid homeopathic drug products, particularly those intended for children.

To address these critical issues, RNA Bio/Pharma is required to take several actions. These include submitting DEG/EG test results for all high-risk component retains or finished product batches within 30 days, and conducting a full risk assessment for all affected drug products, potentially including recalls and implementing robust corrective and preventive actions for their supply chains. The company must also assess biologic substances for sterility and pathogen contamination, and provide detailed quality control specifications and procedures for future component testing.