Biocon Receives EIR for Small Molecules API Manufacturing Facility for Pre -Approval and GMP U.S. FDA Inspection
Bengaluru, Karnataka, India, May 8, 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 Pre-Approval and GMP inspection of its Small Molecules API Manufacturing Facility at Biocon Park SEZ, Bommansandra, Bengaluru, conducted between January 20 and January 24, 2020. At the conclusion of the inspection the agency had issued a Form 483, with five observations, which are being addressed by the Company. The EIR has been closed with a "VAI" classification for the observations.
We remain committed to global standards of Quality and Compliance."