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 has informed that its subsidiary Biocon Biologics’ insulin manufacturing facility in Malaysia completes U.S. FDA (PAI) inspection.
The company informed that the U.S. Food and Drug Administration (US-FDA) conducted an on-site pre-approval inspection (PAI) of the 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, the pharma company said.
“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 US FDA in the stipulated time.”
“We do not expect the outcome of this inspection to impact our commercialization plans for insulin Aspart in the US. Biocon Biologics remains committed to global standards of quality and compliance”, said company spokesperson.