Biocon in a BSE filing said, "The US Food and Drug Administration (USFDA) has issued an Establishment Inspection Report (EIR) 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."
"The USFDA has classified the outcome of this inspection as VAI (voluntary action indicated) and EIR states that the inspection is closed," it added.
Sharing further details with regards to the above development Kiran Mazumdar Shaw, CMD, Biocon said this inspection had thrown up a number of 483s, which had raised a number of concerns.
She said getting a voluntary action indicated (VAI) status on our corrective and preventive action CAPA) plan is very positive news, adding that the company has been told that the May inspection has been closed and they can carry on CAPA implementation.
Therefore, this is a very positive news and hope to cross the finishing line on the target action date, which is December 3, for the biosimilar Trastuzumab, adding that although this news is not directly linked with Trastuzumab, it will have some positive implications.
The target action date is on December 3.
She also clarified that so far they do not supply any products from this facility to US market but if they get the opportunity to produce products from the plant then it would help them, said Mazumdar Shaw.
When asked if they had finished their remediation with regards to Europe and waiting for re-inspection, she said yes.
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