Bengaluru, Karnataka, India, January 27, 2020
"This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Small Molecules API Manufacturing Facility of Biocon Ltd.
At the conclusion of the inspection of the Bengaluru facility, which took place between January 20 and January 24, 2020, the agency issued a Form 483, with five observations.
We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of Quality and Compliance."
- Company Spokesperson