FDA issues Form 483 with 9 observations to Aurobindo Pharma's USA facility

Hyderabad: The US Food and Drug Administration (FDA) has issued a 'Form 483' with nine observations to a manufacturing facility in the USA belonging to AuroLife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma. The plant which makes oral solid manufacturing is situated at Dayton, New Jersey and was inspected by the FDA authorities from January 13, 2020 to February 12, 2020.

"At the end of the inspection, a 'Form 483' has been issued with 9 observations. With respect to the mentioned inspection, we have received a letter from USFDA classifying the inspection as 'Official Action Indicated," Aurobindo Pharma said in a filing with stock exchanges.

The company believes that this OAI classification may not have any material impact on the existing revenues, the supplies of our US business or pipeline products at this juncture, it said.

The exclusive sales from this facility are around 2 per cent of the group turnover and the company will work closely with the regulator to comprehensively address the issues, it further said.

As per the USFDA, aForm483, is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. GDK SS