FDA 483 - EO Products, LLC - November 17, 2020

Small World Trading Company, Inc. in San Rafael, CA, an OTC drug manufacturer, was cited for significant deficiencies in its quality control unit, laboratory controls, and material management. The inspection revealed a lack of written procedures for change management, inadequate investigation of out-of-specification results, and insufficient validation of test methods and supplier analyses for components. These issues indicate a systemic failure to ensure product quality and purity.