FDA 483 - Kay Chemical Company - December 05, 2025

An FDA inspection of Ecolab LLC in Greensboro, NC, a manufacturer of handsoap and hand sanitizer, revealed two significant observations. The firm failed to establish and follow procedures to prevent objectionable microorganisms in drug products, specifically regarding improper equipment storage. Additionally, the written stability program for drug products was found to be deficient, lacking descriptions of storage conditions for samples and an adequately qualified stability chamber.