FDA 483 - Xtreme Tools International, Inc. - January 31, 2025

An FDA inspection of Xtreme Tools International, Inc. in Opa Locka, FL, an OTC drug manufacturer, revealed significant deficiencies in their quality control, production, laboratory, and facility systems. The firm failed to establish adequate written procedures, perform necessary testing and validations, and maintain proper controls over materials, labeling, and the manufacturing environment, indicating a broad lack of cGMP compliance.