New Delhi : Drug firm Divis Laboratories said US health regulator has made five observations after inspection of its manufacturing plant at Visakhapatnam in Andhra Pradesh.
In a regulatory filing, the company said Unit-II at Visakhapatnam, Andhra Pradesh has had an inspection by the US Food and Drug Administration (USFDA) from November 29 to December 6.
“We have been issued a form 483 with five observations and these shall be responded within the time permitted,” it added.
Divis Laboratories set up its second manufacturing facility at Visakhapatnam (Unit-II) in the year 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 manufacturing plant.
Divis Laboratories shares ended at Rs 1,163.60 apiece on the BSE, up 0.91 per cent from previous close.