Aurobindo Pharma received OAI letter from FDA
Aurobindo Pharma received Official Action Indicated letter from USFDA after inspection in october 2019.
Official Action Indicated means objectionable conditions were found and regulatory administrative sanctions by FDA are indicated during inspections. It means an FDA inspection revealed significant objectionable conditions or practices and action must be taken to address the issues.
Aurobindo Pharma intimations dated 7th & 11th October, 2019 with regard to the USFDA inspection of Unit VII, an oral solids formulation manufacturing facility of the Company, Aurobindo Pharma inform you that the Company has received a letter from the USFDA classifying the inspection conducted at the aforesaid facility as Official Action Indicated (OAI).
The Company believes that this OAI classification will not have any material impact on the existing revenues or the supplies to Aurobindo Pharma US business at this juncture. The Company will work closely with the regulator to comprehensively address the issues.