US FDA cautions Aurobindo Pharma’s oral solids formulation facility of regulatory action
According to US FDA's definitions, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during inspections. The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture
Drug firm Aurobindo Pharma recently reported that the US health regulator has cautioned that its oral solids formulation manufacturing facility may be subject to regulatory actions.
The company stressed that it will work closely with the US Food and Drug Administration (US FDA) to comprehensively address the issues.
“Further to our intimations… with regard to the US FDA inspection of Unit VII, an oral solids formulation manufacturing facility of the company, we inform you that the company has received a letter from the US FDA classifying the inspection conducted at the aforesaid facility as official action indicated (OAI),” Aurobindo Pharma said in a filing to BSE.
According to US FDA’s definitions, OAI means “objectionable conditions were found and regulatory administrative sanctions by FDA are indicated” during inspections.
The company said that it believes that this OAI classification will not have any material impact on the existing revenues or the supplies to its US business at this juncture.
The shares of Aurobindo Pharma were trading at Rs 484.50 apiece on BSE, down 4.49 per cent from the previous close.
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