USFDA classifies Aurobindo Pharma arm Bhiwadi facility as OAI
Hyderabad: Aurobindo Pharma has announced that the United States Food and Drug Administration (US FDA) has determined the inspection classification status of the Unit II, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan as ‘Official Action Indicated (OAI).
The USFDA had inspected the facility from April 25th to May 3rd 2024 and issued 7 observations.
Read also: Aurobindo Pharma arm gets 7 USFDA observations for Alwar facility
"The United States Food and Drug Administration (US FDA) had conducted an inspection at UnitII, a Formulation manufacturing facility, of Eugia Pharma Specialities Ltd., a wholly owned subsidiary of the Company, situated at Bhiwadi, Alwar, Rajasthan, from April 25th to May 3rd 2024. Subsequently, the US FDA has determined the inspection classification status of this facility as ‘Official Action Indicated (OAI)," Aurobindo stated in a BSE filing.
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