Biocon receives EIR from USFDA for its Bengaluru facility

The US Food and Drug Administration (USFDA) has sent the report citing closure of inspection of Biocon's sterile drug product manufacturing facility in Bengaluru

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New Delhi: Biocon has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) on the closure of inspection of its sterile drug product manufacturing facility in Bengaluru.

“The company confirms that Biocon has received an EIR from the US-USFDA for its sterile drug product manufacturing facility in Bangalore, following the USFDA pre-approval/inspection of this facility in April/May 2018,” a Biocon spokesperson said in a BSE filing.

It said the EIR notified that the “inspection stands closed”. “Biocon is committed to global standards of quality and compliance,” the statement said.

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.