The U.S. Food and Drug Administration (USFDA) has concluded the inspection at Biocon’s subsidiary -- Biocon Biologics’ (BBL) Biocon Campus (Site 1) facility. USFDA had conducted an inspection at Biocon Biologics’ Biocon Campus (Site 1) facility between February 20-28, 2024.
At the conclusion of this inspection, the agency has issued Form 483s with 4 observations. The Company will submit a comprehensive Corrective and Preventive Action (CAPA) Plan to the U.S. FDA within the stipulated time and is committed to addressing these observations expeditiously. The outcome of this inspection at Site 1 does not impact the manufacturing and distribution of the Company’s commercial products in the US market.
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.
