India’s leading biopharma company Biocon on Saturday said that “It has received three observations for its insulin manufacturing facility in Malaysia from the United States health regulator.”
In a filing with the stock exchange, Biocon, said, “The pre-approval inspection for Insulin Glargine was conducted between February 10 and 21, by the US Food and Drug Administration (USFDA) at the Biocon Sdn Bhd’s manufacturing facility in Malaysia.”
The filing added, “After the inspection, the agency issued a Form 483 with three observations which we believe a procedural in nature.”
According to the USFDA, “Form 483, issued to the firm management after the inspection after investigators observed any conditions that in their judgment may constitute violations of the Food, Drug and Cosmetic Act and related Acts.”
“The FDA has set a target action date for its Insulin Glargine application in June 2020. The company will respond to the FDA with the appropriate Corrective and Preventive Action Plan (CAPA), and we are confident of addressing these observations expeditiously,” the company said.
The company further said, “We believe the outcome of this inspection does not in any way impact the commercialization of Insulin Glargine in the US. Biocon Biologics is committed to global standards of quality and compliance.”