Dr Reddy's issues clarification to USFDA's warning letter for its two units – Firstpost

Last month, the company had received a warning letter from the USFDA relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana Dr Reddy’s Laboratories has submitted a response to the US health regulator on a warning letter it had received last month. “We would like to inform that the company has submitted a response to the US Food and Drug Administration on December 7”, Dr Reddy’s Laboratories said in a filing to the BSE. Last month, the country’s second-largest drug maker had received a warning letter from the USFDA relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana. The US agency had asked the drug maker to provide a comprehensive evaluation of the extent of inaccuracies in recorded and reported data and include a detailed action plan to fully investigate the scale and root causes of “deficient documentation and data management practices”.