The United States Food and Drug Administration (USFDA) conducted a Pre-Approval Inspection (PAI) at new injectable facility of Eugia US Manufacturing (a step-down wholly owned subsidiary of Aurobindo Pharma Ltd.), situated at East Windsor, New Jersey, USA from December 11 to December 22, 2023.

The inspection closed with 10 observations. The observations are procedural in nature and will be responded to within the stipulated time. The plant is yet to start commercial operations.