RNA Bio/Pharma, Incorporated

Warning LetterOpen

Ms. Yvonne E. Grose President and Owner RNA Bio/Pharma, Incorporated 19470 Navarre Coulee Road Chelan , WA 98816-9394 United StatesFEI 3023116Issued Oct 10, 2025Center for Drug Evaluation and Research (CDER)

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3023116.

Violations3

Issue DateOct 10, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: RNA Bio/Pharma, Incorporated
Location: Ms. Yvonne E. Grose President and Owner RNA Bio/Pharma, Incorporated 19470 Navarre Coulee Road Chelan , WA 98816-9394 United States
FEI Number: 3023116
Country: United States
Issue Date: October 10, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

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.

RNA Bio/Pharma, Incorporated FDA Warning Letter, October 10, 2025