USFDA issues official action indicated to Biocon arm's unit in Malaysia

18 Oct 2023 Evaluate

U.S. Food and Drug Administration (USFDA) has issued ‘OAI’ (Official Action Indicated) classification to Biocon’s subsidiary -- Biocon Biologics’ step-down subsidiary -- Biocon Sdn Bhd’s insulins manufacturing facility at Johor, Malaysia. The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility.

Biocon Sdn Bhd has received a communication from USFDA pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Malaysia. The company has submitted a comprehensive corrective and Preventive Action (CAPA) plan to the USFDA in response to observations from the July inspection and believe it is on track to complete all actions as committed.

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.


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