The US Food and Drug Administration (USFDA) has conducted a Post-Approval and GMP inspection of Biocon’s Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, between February 20 and February 26, 2020.
At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature. The company is confident of addressing these observations expeditiously and will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) in a timely manner.
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.
