Biotechnology firm Biocon today said it has received the Establishment Inspection Report with ’voluntary action indicated’ status from the USFDA on closure of inspection of its aseptic drug product facility.
EIR clears the way for exports from the biopharmaceutical company's facility to the US.
“The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report in relation to the cGMP (current good manufacturing practice) inspection of its aseptic drug product facility that was audited between May 25 -June 3, 2017,” Biocon said in a BSE filing.
“The USFDA has classified the outcome of this inspection as VAI (voluntary action indicated) and EIR states that the inspection is closed,” it added.
The company has not elaborated on the VAI status.
The USFDA releases a copy of the EIR to the establishment that was the subject of an FDA or FDA-contracted inspection when the agency determines the inspection to be closed.
Shares of Biocon surged as much as 7.7 per cent to Rs 424.90 against the previous close of Rs 394.35. At the closing trade, the scrip was up 7.27 per cent at Rs 423.