US FDA Issues 5 Observations To Biocon Biologics’ Bengaluru Unit

Biocon Ltd. on Thursday said the US Food and Drug Administration issued five observations after a routine inspection of its subsidiary Biocon Biologics’ drug substance facility in Bengaluru.

The inspection, conducted between August 26 and September 4, covered manufacturing units, analytical and microbiology laboratories, and warehouses.

Biocon said Biocon Biologics will submit a corrective and preventive action plan within the stipulated timeline and is confident of addressing the observations quickly.