BRIEF—Pre-approval US FDA inspection at Biocon's insulins facilities in Malaysia

India’s largest biotech firm Biocon says that its Biocon Sdn Bhd’s insulin glargine drug substance, drug product and device assembly facilities in Malaysia underwent a pre-approval inspection by the US Food and Drug Administration between June 24 and July 5, 2019.

The inspection across these three units concluded with 12 observations issued on the Form 483.

“We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously. We do not expect any change to our commercialization plans for Insulin glargine in the US Biocon remains committed to global standards of Quality and Compliance," said a company spokesperson.