FDA Issues 4 Observations To Biocon's Andhra Pradesh Facility

Biocon, a biotechnology company, reported that the US FDA has issued four observations following its inspection of Biocon's manufacturing plant in Andhra Pradesh. The inspection, focused on Biocon's API facility (Site 5) in Visakhapatnam, Andhra Pradesh, concluded on June 21, 2024, according to a regulatory filing by the company. It also added that "Four observations were cited at the end of the inspection, which we will be addressing within the stipulated time.”