Biocon has informed that the US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the API Manufacturing Facility of the Company. 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. It will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. It remains committed to global standards of Quality and Compliance.
The above information is a part of company's filings submitted to BSE.
