The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma Limited's Unit III, a Formulation manufacturing facility situated at Bachupally Village, Medchal Malkajgiri District, Telangana, from 14th July to 21st July 2023. At the end of the inspection, we have been issued a 'Form 483' with 3 observations.

The observations are procedural in nature. We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observations at the earliest.