Aurobindo Pharma Gets EIR With VAI Status From U.S. FDA For Hyderabad Facility
Objectionable conditions were found but the U.S. agency is not prepared to recommend any administrative or regulatory action.
Aurobindo Pharma Ltd on Wednesday said that it has received an establishment inspection report from the U.S. health regulator with Voluntary Action Initiated status for its Unit VIII manufacturing facility in Hyderabad.
"Further to our intimation dated Nov. 6, 2019 with regard to the USFDA inspection of Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad, we would like to inform that the company has received the Establishment Inspection Report with VAl status from the U.S. FDA," the drug firm said in a filing to BSE.
According to the U.S. health regulator, a VAI classification means “objectionable conditions or practices were found but the agency is not prepared to take or recommend any administrative or regulatory action.”
USFDA issues an EIR to the company when an inspection is satisfactorily closed.
Shares of Aurobindo Pharma were trading at Rs 508.50 a piece on BSE, up 0.87 percent from the previous close.