Missing Testing for Toxic Impurities and Lack of Stability Data in OTC Drug Products: FDA Warning Letter

In a Warning Letter dated 9 April 2025 and published on 29 April 2025, the FDA identified serious CGMP violations at a U.S.-based OTC drug manufacturer, Dyno Manufacturing, Inc. following an inspection from 28 October to 1 November 2024. The firm failed to conduct identity testing on high-risk raw materials like glycerin, propylene glycol, and ethanol, relying solely on supplier certificates despite risks of toxic contaminants such as diethylene glycol and methanol. No stability studies supported assigned shelf lives for OTC products, and the company lacked a formal stability program or adequate testing to ensure product quality over time. Additionally, processes and equipment for manufacturing liquid hand sanitizers and antibacterial soaps were unvalidated, with no cleaning validation performed. The Quality Unit was deficient in oversight, missing written procedures, annual product reviews, and controls for data integrity. The FDA urged corrective actions and recommended hiring a qualified GMP consultant, warning that continued non-compliance could lead to further enforcement. More details are available on the FDA website. 

19-05-2025