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Aurobindo plant gets relief from USFDA
Aurobindo Pharma on Tuesday 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)
Hyderabad: Aurobindo Pharma on Tuesday 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.
"The USFDA has determined that the inspection classification of this facility is VAI," it added.
