Biocon receives EIR from US FDA

EIR clears the way for exports from the biopharmaceutical company’s facility to the US

Biotechnology firm Biocon has received the Establishment Inspection Report (EIR) with ’voluntary action indicated’ status from the US FDA 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 (US FDA) 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.