Divi’s Lab in July announced that US FDA had moved to lift Import Alert 99-32 imposed on the unit. New Delhi: Drug firm Divi’s Laboratories Ltd on Friday said the US Food and Drug Administration (FDA) has “closed out” a warning letter issued to a unit at Visakhapatnam following evaluation of corrective actions taken by the company at the plant. Last week, Divi’s Laboratories had informed that the US FDA would lift an import alert imposed on the company’s unit-II in Visakhapatnam and was moving to close out the warning letter issued to the unit. The company in July announced that US FDA had moved to lift Import Alert 99-32 imposed on the unit. As per US FDA, an import alert under 66-40 entails “detention without physical examination” of drugs from firms which have not met drug GMPs, while alert under 99-32 is issued to “firms refusing FDA foreign establishment inspection”.

Source: Mint November 10, 2017 06:00 UTC