Today morning, Aurobindo Pharma announced that after the USFDA conducted inspection of its Unit VII, an oral solids formulation manufacturing facility, it has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as Official Action Indicated (OAI).
According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections.
OAI means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.
The company believes that this OAI classification will not have any material impact on the existing revenues or the supplies to our US business at this juncture. The Company will work closely with the regulator to comprehensively address the issues.
The market is not soothed by these words of the company. In the morning, before the news came in the stock opened higher at Rs.508.80 v/s its close yesterday at Rs.507.30. But once this announcement came, the stock slipped down to 466.75 and is currently the top loser on the BSE.