Aurobindo Pharma's 3 facilities classified as 'Official Action Indicated'
The US Food and Drug Administration has classified Aurobindo Pharma's three facilities under Official Action Indicated (OAI).
Hyderabad: The US Food and Drug Administration has classified Aurobindo Pharma's three facilities under Official Action Indicated (OAI).
Aurobindo Pharmasaid they have received letters from the FDA, classifying the inspections at its API (Active Pharmaceutical Ingredient) facilities of Unit I and XI and intermediates facility of unit IX in February 2019 as Official Action Indicated (OAI).
According to FDA's definitions, Official Action Indicated means "objectionable conditions were found and regulatory and/or 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 has already submitted its initial response to USFDA. The Company is sending further updates on the committed corrective actions,"the drug maker said.
Aurobindo Pharma is confident these OAI classifications would not have an impact on disruption of supplies or revenue from operations of these facilities, it added.