Aurobindo Pharma’s new injectable facility in East Windsor, New Jersey, underwent a Pre-Approval Inspection (PAI) by the US FDA from December 11 to December 22, 2023. The inspection resulted in 10 procedural observations. The company stated that these observations, considered procedural in nature, will be addressed within the stipulated timeframe. The facility, operated by Eugia US Manufacturing LLC, a wholly-owned subsidiary of Aurobindo Pharma, is currently not in commercial operation. This development marks a step forward for Aurobindo Pharma as it navigates regulatory processes for its new manufacturing unit in the United States.
Aurobindo Pharma’s New Facility Clears FDA Inspection with Procedural Observations
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