Divi's Labs barred from exports to US after FDA import alert on Vizag unit

Unit under lens makes up 65% of firm's total sales; 15% of US sales could be hit, 10 products spared

In a big setback to Hyderabad-based active pharmaceutical ingredients (APIs) maker Divi's Laboratories Limited, the US Food and Drug Administration (USFDA) has issued an import alert on the company's Unit 2 facility at Visakhapatnam, Andhra Pradesh, though with certain exemptions.

The latest action comes after Divi's management had submitted a 700-page response in the light of Form 483 observations issued by the US drug regulator in December 2016. 

On December 7, 2016, the USFDA inspection team issued a Form 483 with five observations citing lack of proper control over computer systems, lack of proper maintenance of equipment and the documents