HYDERABAD: Dr Reddy’s Laboratories Ltd (DRL) on Thursday said the US FDA has given two more weeks to reply to the warning letter issued to the company. DRL has to furnish its responses by December 7.
“The company is in the process of preparing a response to FDA’s warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the company’s response to its warning letter,” DRL said in a statement. The FDA had earlier set a deadline for the company to respond within 15 days from the date of receiving the letter.
The US health regulator, which issued a warning letter to DRL on November 5 on three of its plants, said it found several violations with regard to current good manufacturing practices (CGMP). It also cautioned that it may withhold approval to any new drugs or Active Pharmaceutical Ingredients (API) and stop importing if the company “fails to correct the violations.” It said its inspectors have discovered “an uncontrolled custom QC laboratory (CQC)” at DRL’s Srikakulam unit. The letter had asked Dr Reddy’s for a third party assessment of comprehensive evaluation of the extent of inaccuracies in recorded and reported data.