With 9 observations and "Official Action Indicated" classification
Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) inspected AuroLife Pharma LLC's oral solid manufacturing facility situated at Dayton, New Jersey, a wholly owned step-down subsidiary of the Company, from 13 January to 12 February 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".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. The exclusive sales from this facility is around 2% of the group turnover. The Company will work closely with the regulator to comprehensively address the issues.
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