Aurobindo's US manufacturing facility gets inspectional observations

The US Food and Drug Administration (US FDA) has issued a Form 483 with 9 observations to AuroLife Pharma LLC's oral solid manufacturing facility situated at Dayton, New Jersey, a wholly owned step-down subsidiary of Aurobindo Pharma Limited.
 

The US drug regulator inspected the plant from January 13 to February 12,2020 and issued a letter to the company to this effect while classifying the inspection as 'Official Action Indicated'.

Informing the development to the stock exchanges on Thursday, Aurobindo management said that this OAI classification may not have any material impact on the existing revenues, the supplies of its US business or pipeline products at this juncture.

The exclusive sales from this facility is around 2 per cent of the group's turnover, according to the filing. "The company will closely work with the regulator to comprehensively address the issues," Aurobindo said.