Dr Reddy's Laboratories Ltd, a Rs.14,800 crore India's second-largest pharmaceutical company, has received a warning letter from the US Food and Drug Administration over inadequate quality control procedures at three manufacturing plants in India.

Dr Reddy's shares declined sharply almost by 13 per cent in the morning session today to Rs.3707.40 from its yesterday close of Rs.4252.60 on the BSE. The scrip touched to its 52-week highest level at Rs.4382.95 on October 20, 2015.

DRL issued a statement acknowledging that it has received a warning letter issued by the US FDA dated November 5, 2015 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as oncology formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. This action follows the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015 respectively.

G V Prasad, CEO, said, “We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days. We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes, as an organisation-wide priority.”