Biocon on Saturday said it has received three observations from the US health regulator following inspection of its insulin manufacturing facility in Malaysia.
The US Food and Drug Administration (USFDA) had conducted a pre-approval inspection of Biocon’s subsidiary Biocon Sdn BHd’s manufacturing facility in Malaysia for Insulin Glargine between February 10 and 21.
“At the conclusion of the inspection, the agency issued a Form 483 with three observations which we believe are procedural in nature,” a Biocon spokesperson said in a regulatory filing.
As per the USFDA, Form 483 is issued to firm management at the conclusion of an inspection when investigators have observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts.
“We will respond to the FDA with an appropriate Corrective and Preventive Action Plan (CAPA) and we are confident of addressing these observations expeditiously,” the company added.
The FDA has set a target action date for its Insulin Glargine application in June 2020, it said.
“We believe the outcome of this inspection does not in any way impact the commercialisation plans of Insulin Glargine in the US. Biocon Biologics is committed to global standards of quality and compliance,” the spokesperson said.