Biocon’s Bengaluru Unit Receives EIR From U.S.FDA

Biotechnology firm Biocon Ltd. today said it has received Establishment Inspection Report (EIR) from the U.S. health regulator on closure of inspection of its sterile drug product manufacturing facility in Bengaluru.

"The company confirms that Biocon has received an EIR from the U.S. Food and Drug Administration for its sterile drug product manufacturing facility in Bangalore, following the U.S. FDA pre-approval/inspection of this facility in April/May 2018," a Biocon spokesperson said in a BSE filing. It added that the EIR notified that the "inspection stands closed".

The U.S. FDA 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.