FDA 483 - Mixie - June 18, 2025

An FDA inspection conducted from June 16-18, 2025, at a drug manufacturing facility in Eagan, MN, identified two significant observations. The inspection, overseen by Investigator Beatrix D. Hippe and addressed to General Manager Thomas A. Ryan, highlighted deficiencies related to component testing and equipment maintenance procedures. The first observation noted that the company does not conduct specific identification tests on components, instead relying on supplier-provided certificates of analysis. Specifically, full identity testing for propylene glycol raw material, including quantification of diethylene glycol and ethylene glycol and purity verification, was not performed. Secondly, the inspection found a lack of written procedures for the cleaning and maintenance of equipment. Notably, there were no documented cleaning procedures for holding tanks used to store unscented hand sanitizer, a drug product containing the high-risk component propylene glycol. These observations indicate non-compliance with established quality and manufacturing standards, as regulated by the Federal Food, Drug and Cosmetic Act. The company is expected to address these deficiencies by implementing robust testing protocols for raw materials and establishing comprehensive written procedures for equipment cleaning and maintenance to ensure product quality and safety.