The U.S. Food and Drug Administration (U.S. FDA) conducted an on-site pre-approval inspection (PAI) of Biocon’s Malaysian subsidiary Biocon Sdn recently. the Malaysia facility is for the production of insulin Aspart.

After the inspection, the agency has issued a Form 483 with a total of 6 observations across drug substances, drug products and devices facilities.

According to a company spokesperson, "We are confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA), which will be submitted to the U.S. FDA in the stipulated time. We do not expect the outcome of this inspection to impact our commercialisation plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of quality and compliance."