A new injectable facility of Aurobindo Pharma’s step-down subsidiary Eugia US Manufacturing LLC in New Jersey, U.S., has been issued 10 observations by the United States Food and Drug Administration (U.S. FDA) after a pre-approval inspection.
“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,” the drugmaker said in a filing on Sunday. The U.S. FDA had inspected the facility from December 11-22.
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