Aurobindo arm’s Rajasthan unit classified OAI by U.S. FDA

The U.S. Food and Drug Administration (U.S. FDA) has classified Aurobindo Pharma subsidiary Eugia Pharma Specialities’ Unit-II in Bhiwadi, Rajasthan, as Official Action Indicated (OAI).

The classification of the formulations manufacturing unit follows the inspection in November at the end of which the U.S. FDA. had issued a Form 483 with nine observations.

“At this point in time, the company doesn’t foresee any impact on the business. The company is committed to maintaining the highest quality manufacturing standards at all of its facilities,” Aurobindo Pharma said in a filing on Tuesday evening.

On Wednesday, the parent company’s shares closed 1.43% lower at ₹1,269 apiece on the BSE.

OAI is one of the three classifications the U.S. FDA categorises its inspection and means regulatory and/or administrative actions are recommended.

The other two are no action indicated (NAI) conveying that no objectionable conditions or practices were found during inspection; and voluntary action indicated (VAI), which means objectionable conditions or practices were found, but the regulator is not prepared to take or recommend any administrative or regulatory action.