Bengaluru, Karnataka, India, Feb 22, 2020
This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of our subsidiary, Biocon Sdn. Bhd’s Insulins manufacturing facility based in Malaysia, for Insulin Glargine, between Feb 10 and Feb 21, 2020.
At the conclusion of the inspection, the agency issued a Form 483 with 3 observations which we believe are procedural in nature.
We will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. The FDA has set a Target action date for our Insulin Glargine application in June 2020. We believe the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the US. Biocon Biologics is committed to global standards of Quality and Compliance.”
- Company Spokesperson