Aurobindo Pharma gets official action indicated classification from USFDA for its plant
New Delhi: Aurobindo Pharma has announced that the US Food and Drug Administration (FDA) classified the inspection of the company's oral solids formulation manufacturing facility of Unit VII 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 our US business at this juncture," Aurobindo Pharma said in a BSE filing.
The company will work closely with the regulator to comprehensively address the issues.
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.