The United States Food and Drugs Administration (USFDA), which had issued a 15 days deadline to respond to its warning letters issued to Dr. Reddy’s laboratories has extended it to 2 weeks more till December 7.
With USFDA issued warnings to 3 units of Dr. Reddy’s labs in Telangana and Andhra Pradesh, over issues relating to quality control, the drug maker has got a respite from the regulator as it has extended the reply deadline from the company by December 7.
This has given a big relief to Dr. Reddy’s as the company may get some more time to respond to the regulators’ concerns. Earlier on November 5, the drug major received warning letters from the USFDA and directed the company to send its responses within 15 days. But, as the time is very short and it takes more than one month to prepare a detailed response report, the drug major requested USFDA to extend the time and it had given it a positive nod by extending the reply time till December 7.
“The company is in the process of preparing a response to the FDA’s warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the company’s responses to its warning letter,” informed a company official.
Earlier, the USFDA in its warning letters issued to Dr. Reddy’s labs observed several violations with regard to the current good manufacturing practices (CGMP). It asked Dr. Reddy’s for a third party assessment of comprehensive evaluation of the extent of inaccuracies in recorded and reported data.
The letter also asked for a management strategy that includes global corrective action and preventive action.
The three plants of Dr. Reddy’s that came under USFDA scanner include API manufacturing facilities at Srikakulam and oncology formulations manufacturing facility at Duvvada, both in Andhra Pradesh. The third plant is API manufacturing facility in Miralaguda of Nalgonda district in Telangana state.