Biocon has received the Establishment Inspection Report, from the USFDA with voluntary action indicated status, on closure of inspection of its aseptic drug product facility.

In a BSE filing Biocon stated, “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.”

Further it stated that, the outcome of inspection has been classified by USFDA as VAI (voluntary action indicated) and EIR has stated that, inspection has been closed.

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