Dr. Reddy’s Laboratories has received warning letters from the U.S. FDA for three key Indian facilities manufacturing APIs and oncology drugs.
The FDA inspected manufacturing sites in Srikakulam, Miryalaguda and Duvvada in November 2014, January and February of this year, and almost immediately issued initial notices asking India’s second largest pharmaceutical company to rectify quality control issues.
After the drug maker failed to fix issues to the satisfaction of the agency, the FDA issued a warning letter last week for the three facilities.
According to Reuters, the affected plants account for more than 10 percent to 12 percent of the company's sales.
In a press statement, Dr. Reddy’s CEO, G V Prasad commented, “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 organization-wide priority.”
Read the Reuters article