The United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma’s Unit XI, an API non-antibiotic manufacturing facility situated at Pydibhimavaram, Srikakulam District, Andhra Pradesh, from July 25 to August 2, 2022.

The said Unit has been classified as OAI on May 17, 2019 and subsequently given a warning letter dated June 20, 2019. The company has responded to the warning letter and carried out the committed corrections. The US FDA authorities have inspected the facility from July 25 to August 2, 2022.

At the end of the inspection, we have been issued a 'Form 483' with 3 observations and none of these observations are related to data integrity. We will respond to the US FDA within the stipulated timeline and work closely with USFDA to address the observations at the earliest.