The US Food and Drug Administration (US-FDA) has conducted an on-site pre-approval inspection (PAI) of Biocon Malaysian subsidiary Biocon Sdn. Bhd's manufacturing facility for Insulin Aspart between Sep 13 and Sep 24, 2021.
At the conclusion of the inspection, the agency has issued a Form 483 with a total of 6 observations across Drug Substance, Drug Product and Devices Facilities.
Biocon says it is confident of addressing these observations through procedural enhancements and an appropriate Corrective and Preventive Action Plan (CAPA).
"[This CAPA] will be submitted to the US 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," the company stated. "Biocon Biologics remains committed to global standards of Quality and Compliance."