Divi's Labs said it has already filed its detailed response to Form 483 observations of the US regulator.
"The company has already filed its detailed response to the 'Form 483' observations of the USFDA (US Food and Drug Administration) within the time permitted," Divi's Laboratories said in a regulatory filing.
Last month, the US regulator had made five observations after inspection of the company's manufacturing plant at Visakhapatnam.
Divi's Laboratories set up its second manufacturing facility at Visakhapatnam (Unit-II) in 2002 on a 350-acre site.
The site has 14 multi-purpose production blocks. The company manufactures active pharmaceutical ingredients (APIs) and intermediates for generics among others at the plant.
At 1:31 p.m., shares in Divi's Laboratories were trading 0.05 per cent higher at Rs 737.80 apiece on the BSE, whose benchmark Sensex index was down 0.02 per cent.
