Divi’s said it has taken up appropriate remediation measures to address the concerns raised by USFDA
Drug firm Divi’s Laboratories said US health regulator will lift an import alert imposed on the company’s Unit—II at Visakhapatnam.
The company “has been informed by the United States Food and Drug Administration (USFDA) that it will lift the Import Alert 99—32 imposed on the company’s Unit—II at Visakhapatnam,” Divi’s Laboratories said in a filing to BSE.
The company had earlier said that the US FDA had issued an import alert under clauses 99—32 and 66—40 in March, and a warning letter later for the Vishakhapatnam facility.
As per the US Food and Drug Administration (USFDA), 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“.
The company has filed detailed responses and given updates to the Form—483 as well as the warning letter within the stipulated time, it added.
Divi’s said it has taken up appropriate remediation measures to address the concerns raised by USFDA and awaits further action from the regulator in this regard.