The United States Food & Drug Administration (USFDA) is all set to lift the Import Alert 99-32 imposed on Divi’s Laboratories Unit-II at Visakhapatnam. The USFDA issued an Import Alert under clauses 99-32 and 66-40 in March of 2017 and a warning letter in May of 2017 for the company’s Vishakhapatnam facility.
The company filed detailed responses and given updates to the Form-483 and the warning letter within the stipulated time. Divi’s Laboratories, along with its external consultants, specialists and subject matter experts, has taken up appropriate remediation measures to address the concerns raised by USFDA. The company awaits further action from USFDA in this regard. The above development illustrates the company’s commitment to work closely with the USFDA and its efforts towards compliance to cGMP regulations.
Divi’s Laboratories focussed on developing new processes for the production of Active Pharma Ingredients (APIs) & Intermediates. The company in a matter of short time expanded its breadth of operations to provide complete turnkey solutions to the domestic Indian pharmaceutical industry.
