The United States Food and Drug Administration (USFDA) issued 10 observations after conducting a pre-approval inspection at a facility linked to wholly-owned arm of Aurobindo Pharma in New Jersey, a regulatory filing stated on December 24.

The American drug regulator conducted the inspection at "new injectable facility of Eugia US Manufacturing LLC, situated at East Windsor, New Jersey, USA from December 11 to December 22, 2023," Aurobindo Pharma said, adding that "the inspection closed with 10 observations".

"The observations will be responded to within the stipulated time. The plant is yet to start commercial operations," the Indian pharma major further stated.