U.S. FDA Issues Form 483 With Nine Observations To Aurobindo Pharma’s U.S. Facility
The U.S. Food and Drug Administration has issued a 'Form 483' with nine observations to a manufacturing facility in the U.S. belonging to AuroLife Pharma LLC, a wholly owned step-down subsidiary of Aurobindo Pharma Ltd.
The plant which makes oral solid manufacturing is situated at Dayton, New Jersey and was inspected by the FDA authorities from Jan. 13, 2020 to Feb. 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 U.S. business or pipeline products at this juncture, it said.
The exclusive sales from this facility are around 2% of the group turnover and the company will work closely with the regulator to comprehensively address the issues, it further said.
As per the U.S. FDA, a Form 483 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 Act and related Acts.