Dr Reddy’s Laboratories announced today that it has received a warning letter issued by the US FDA dated November 5 relating to its API manufacturing facilities situated at Srikakulam (Andhra Pradesh) and Miryalaguda (Tamil Nadu), and also at its Oncology formulation manufacturing facility located in Duvvada (Andhra Pradesh).
The action follows the earlier inspections held by the US drug regulator in November 2014, January 2015 and February 2015, respectively.
G V Prasad, CEO, Dr Reddy's, said, "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."
The action follows the earlier inspections held by the US drug regulator in November 2014, January 2015 and February 2015, respectively.
G V Prasad, CEO, Dr Reddy's, said, "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."
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