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Biocon facility gets inspection closure report from USFDA

 

New Delhi: Biotechnology firm Biocon on Monday 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.

“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. The stock of Biocon was trading at Rs 413.60, up 4.88 per cent from its previous close, on the BSE.

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