The US Food and Drug Administration (USFDA) has conducted two cGMP inspections at Biocon Biologics’ subsidiary -- Biocon Sdn. Bhd’s Insulins Manufacturing Facility in Malaysia, encompassing Biologics Drug Substance, Drug Product units and Quality Control laboratories, as well as the Delivery Devices unit. These inspections were conducted between July 10 and July 20, 2023. Biocon Biologics is the biosimilar arm of Biocon.
At the conclusion of these inspections, the agency issued a Form 483 with 6 observations for Drug Substance, Drug Product units and Quality Control laboratories as well as 2 observations for the Delivery Devices unit. These observations primarily relate to enhancing operational procedures and strengthening training programs. The inspections did not identify any data integrity breaches or systemic non-compliance.
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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