Decoding the US drug regulator’s actions on pharma plants
Does the issue of multiple observations to a plant site by the US drug regulator USFDA mean it will get a Warning Letter? Why is it that some companies that are issued just a few observations get Import Alerts? Why do some companies take years to solve USFDA regulatory problems? Does India face a ‘culture’ problem when it comes to lack of compliance? Amit Rajan, an expert on quality and compliance issues, answers these and many more questions on a critical part of the operations of pharma companies in this week’s podcast. He breaks down the basics of Form 483s, EIRs and the FDA. Tune in!