The US Food and Drug Administration (USFDA) has completed a pre-approval inspection of Biocon’s sterile drug product manufacturing facility in Bangalore this week and issued a Form 483 with 7 observations. The observations are largely procedural and aimed at continuous improvement. The company will respond to the USFDA with a corrective and preventive action plan in a timely manner.
Besides, the company has received the preliminary report from the European Regulator post inspection of its sterile drug product facility in Bangalore in March 2018. The report lists 6 major observations with no observation classified as critical. The company will submit a corrective and preventive action plan to the European inspection agency within the stipulated time period.
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.
