FDA 483 - Divi's Laboratories Ltd. (Unit II) - July 19, 2024

An FDA inspection of Divi's Laboratories Ltd. (Unit II) in Visakhapatnam District, India, an API manufacturer, revealed a significant deficiency in their equipment cleaning procedures. The firm failed to establish adequate written procedures for cleaning equipment used in API manufacturing, specifically lacking provisions for cleaning or visually inspecting areas behind certain equipment components. This indicates a moderate severity issue related to facility and equipment control.