Aurobindo Pharma said the US health regulator has decided that the inspection classification of company’s injectable formulation manufacturing facility at Hyderabad is voluntary action indicated (VAI). As per the USFDA, a VAI inspection classification indicates that although investigators found and documented objectionable conditions during the inspection, FDA will not take or recommend regulatory or enforcement action because the objectionable conditions do not meet the threshold for action at this time.
The inspection of Unit IV at Hyderabad, an injectable manufacturing formulation facility of the company, was conducted between November 4-13, 2019 by the United States Food and Drug Administration (USFDA), Aurobindo Pharma said in a filing to the BSE. ‘The USFDA has determined that the inspection classification of this facility is VAI,’ it added.
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Shares of Aurobindo Pharma were trading at Rs 631 per scrip on BSE, up steep 16.73 per cent from its previous close.