Dr Reddy’s responds to USFDA on quality issues
City-based Dr Reddy\'s Laboratories on Wednesday said it had submitted a response to the US health regulator on a warning letter it had received last month.
Hyderabad: City-based Dr Reddy's Laboratories on Wednesday said it had 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 (USFDA) on December 7", the pharma major said in a release.
Last month, the company received a warning letter from the USFDA relating to quality control issues at two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.
In the warning letter, the US health regulator 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’.
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