Biocon’s Bengaluru API Unit Gets Two Observations By USFDA

Biocon informed the exchanges today that the U.S. Food and Drug Administration (USFDA) conducted a Post-Approval and GMP inspection the company’s Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru, between Feb 20 and Feb 26, 2020.

At the conclusion of the inspection the agency issued a Form 483, with two observations, which are procedural in nature. The company further mentioned that it is confident of addressing these observations expeditiously and will respond to the FDA with a Corrective and Preventive Action Plan {CAPA) in a timely manner.

“We remain committed to global standards of Quality and Compliance.” – Company Spokesperson.-India Infoline