FDA 483 - Havix Group Inc - July 25, 2025

An FDA inspection of Havix Group Inc in Hoschton, GA, a drug manufacturer, revealed significant deficiencies in process validation, equipment cleaning procedures, and personnel gowning practices. The firm failed to adequately address the potential impact of operating at extreme batch record ranges on product quality and stability. Additionally, cleaning procedures for equipment were found to be deficient, and an operator was observed not wearing required protective apparel while handling drug product.