MUMBAI, April 4 India's Dr Reddy's Laboratories
Ltd said on Tuesday that the U.S. Food and Drug
Administration has outlined two more concerns with the company's
Srikakulam drug-making plant after an inspection of the
Dr Reddy's, which derives a majority of its sales from the
United States, said in statement that it had received an
inspection letter known as 'form 483' from the FDA about the
Srikakulam plant and was addressing the concerns.
It did not say what the FDA observations were, and the FDA
typically does not make such letters public.
The Srikakulam plant was one of Dr Reddy's main facilities
for producing active pharmaceutical ingredients (APIs) but
production was hit after the FDA issued a warning over
inadequate quality control practices there in 2015.(reut.rs/2o5AOfa)
India's second-biggest drugmaker by sales has said it has
since been working on improving its processes at the plant, but
in the meantime some of its other important facilities have also
faced FDA restrictions over similar problems.
(Reporting by Zeba Siddiqui; Editing by Greg Mahlich)