Biocon’s insulin manufacturing facility in Malaysia gets 3 observations

The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) of Biocon Ltd’s subsidiary, Biocon Sdn. Bhd’s Insulins manufacturing facility based in Malaysia, for Insulin Glargine, between February 10 and February 21, 2020. At the conclusion of the inspection, the agency issued a Form 483 with 3 observations, which the company believes are procedural in nature.
The company 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 Insulin Glargine application in June 2020. The company believes that the outcome of this inspection does not in any way impact the commercialization plans of insulin glargine in the US.