A Warning Letter has been issued to Aurobindo Pharma Limited (Aurobindo) for its Unit-XI, an Active Pharmaceutical Ingredient (API) unit in Srikakulam, one of the three plants that received Official Action Indicated (OAI) status in May 2019. The letter mainly pertains to the ongoing issues regarding impurities in Sartan's. The company proposes to enter into dialogue with the US FDA over the next 1520 days to decide a future course of action. From Unit XI, the company...