Biocon has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) 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.
Biocon is India’s largest and Asia’s leading Biotechnology Company with a strategic focus on biopharmaceuticals and research services. It is a fully integrated, innovation-driven biopharma enterprise offering affordable solutions for chronic diseases to patient's worldwide.
