The United States Food and Drug Administration (USFDA) inspected Unit-II, an API manufacturing facility, of Apitoria Pharma Private Limited, a wholly owned subsidiary of Aurobindo Pharma Ltd., situated at Gaddapotharam Village IDA, Jinnaram Mandal, Sanga Reddy District, Telangana from September 23 to 27, 2024.

The inspection closed with 10 observations. The observations are of procedural in nature and will be responded to within the stipulated time.

The US FDA audit concluded on Friday, September 27, 2024 at 8.00 PM. Because of non-availability of senior technical team to review the nature of observations, there is a delay in intimation.