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
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.
© Thomson Reuters 2017