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Biocon Receives EIR for Small Molecules API Manufacturing Facility for Post – Approval and GMP U.S. FDA Inspection

  • Posted by: BIOCON


Company Statement

Bengaluru, Karnataka, India, March 20, 2020

“This is to inform you that Biocon has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the Post-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, conducted between Feb 20 and Feb 26, 2020. The EIR has been closed with a “VAI” classification for the observations. At the conclusion of the inspection last month the agency had issued a Form 483, with two observations, which were procedural in nature and are being addressed by the Company.

We remain committed to global standards of Quality and Compliance.”

– Company Spokesperson

Author: BIOCON