This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a Post-Approval and GMP inspection of our 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. We are 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.
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