Aurobindo Pharma gets EIR with VAI classification from USFDA for Hyderabad unit
Feb 19, 2020, 16:55 IST
New Delhi, Feb 19 () Drug firm Aurobindo Pharma on Wednesday said it has received an establishment inspection report from the US health regulator with voluntary action indicated (VAI) status for its Unit-IV facility in Hyderabad.
The United States Food and Drug Administration (USFDA) had in November 2019 issued a Form 483 with 14 observations after the inspection of its Unit-IV, a general injectable formulation manufacturing facility situated at Hyderabad.
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The regulator had inspected the facility from November 4 to November 13 last year, Aurobindo Pharma said.
"The company has received the establishment inspection report (EIR) with VAI status from USFDA," Aurobindo Pharma said in a regulatory filing.
According to the US 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".
Shares of Aurobindo Pharma on Wednesday rose 20.40 per cent to close at Rs 602.25 per scrip on the BSE. AKT HRS(This story has not been edited by www.businessinsider.in and is auto–generated from a syndicated feed we subscribe to.)