US FDA sounds import ban on Dr Reddy's drugs for several violations

The regulator said it had found several violations with regard to current good manufacturing practices at three of its plants Hyderabad: The US Food and Drug Administration, which had issued a warning letter to Dr Reddy’s Laboratories over quality issues, has said it might withhold approval of the company’s fresh drugs and stop import if no corrective action is taken. The regulator said it had found several violations with regard to current good manufacturing practices at three of its plants. “FDA strongly recommends that you evaluate global manufacturing operations to ensure compliance with CGMP regulations and requirements, comprehensively and immediately,” the regulator said in its letter on November 5 addressed to Satish Reddy, DRL Chairman. “Until you complete all corrections and FDA confirms your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm as a drug product or API manufacturer.” Earlier this month, the country’s second-largest drug maker received a warning letter from the US drug regulator relating to two of its API manufacturing plants and a formulation plant in Andhra Pradesh and Telangana.