The United States Food and Drug Administration (USFDA) inspected the Aurobindo’s Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to 18, 2022, as per the company’s stock regulatory filing.

The said Unit had been classified as Official Action Indicated (OAI) on May 17, 2019, and the company had responded to the agency and carried out the required corrective actions, as per the company's statement.

According to the USFDA site, the company's unit 11 has already been classified as "voluntary action indicated," which means objectionable practises were found at the manufacturing unit. However, the USFDA does not recommend any administrative or regulatory action.

The API non-antibiotic manufacturing firm Unit 11 in Andhra Pradesh's Srikakulam District was inspected by the US FDA in February 2019, followed by a warning letter in June 2019, and an inspection on July 25 to August 2 2022.

The company also stated that it will respond to the USFDA within the timeframe specified and will work closely with the agency to address the observations as soon as possible.