India’s leading biopharma company, Biocon Limited on Thursday said that “It has received a Form 483 and two observations for its Small Molecules API Manufacturing facility in Bengaluru.”
In a filing with the Bombay Stock Exchange, the company said, “The Post-Approval and GMP inspection was conducted between Feb 20 and Feb 26, 2020, by the U.S. Food and Drug Administration (USFDA) at our Small Molecules API Manufacturing Facility at 20th KM, Biocon Campus, Bengaluru.”
“After the inspection, Form 483, with two observations, which are procedural in nature, was issued to the company by the USFDA,” the filing said.
“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,” the company said.
“We remain committed to global standards of Quality and Compliance,” it added.