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