Biocon receives three US FDA observations on its Telangana plant

Biotechnology major Biocon on Thursday said the US health regulator has issued three observations after inspecting its Telangana-based manufacturing plant.

The US Food and Drug Administration (USFDA) concluded a pre-approval inspection for Site 3 located at Hyderabad on July 20, Biocon Ltd said in a regulatory filing.

''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, the Bengaluru-based company said.