Biotech major Biocon has received three observations from the United States Food and Drug Administration (FDA) after the global regulatory authority inspected its Telangana-based manufacturing plant.
The US Food and Drug Administration concluded a pre-approval inspection for Site 3 located at Hyderabad on July 20, Biocon Ltd said in a regulatory filing on the bourses.
"Three observations were cited at the end of the inspection, which we will be addressing within the stipulated time," it added.
The company stands committed to quality, safety and efficacy of its products, stated the Biocon.
