HYDERABAD: Biotechnology major Biocon on Monday said that the US FDA had issued 12 observations after the inspection of three of its units in Malaysia.
Biocon Sdn Bhd’s insulin glargine drug substance, drug product and device assembly facilities in Malaysia had a pre-approval inspection by the FDA between June 24 and July 5, Biocon said in a filing with BSE.
“The inspection across these three units concluded with 12 observations issued on Form 483,” it added.
Form 483 notifies the company of objectionable conditions.
“We will respond to the FDA with a corrective and preventive action plan and are confident of addressing these observations expeditiously,” the statement said.
Biocon does not expect any change to its commercialisation plans for insulin glargine in the US.