Firm will respond with a 'comprehensive plan' to address the issues
Dr. Reddy’s Laboratories has received a warning letter from the US FDA relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as an oncology formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh.
The letter follows FDA inspections of these sites in November 2014, January 2015 and February 2015, respectively.
Dr Reddy's has not revealed the nature of the cGMP issues, but Chief Executive G V Prasad said the company took the matter seriously and would work quickly to resolve them.
'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,' he said.
Prasad said in a conference call with analysts that the FDA wanted Dr Reddy's to use outside auditors to evaluate product quality and some of its processes. He said any corrective measures would be implemented across all its sites, which would take 'significant effort and time'.