Biocon gets three 'observations' from FDA for insulin facility in Malaysia

24 February 2020

India's Biocon (BSE:532523), Asia's premier biotechnology company, revealed that the US Food and Drug Administration had conducted a pre-approval inspection of its 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 website posting.

A Form 483 is issued by the US regulator to company 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 in the USA. Biocon Biologics is committed to global standards of quality and compliance," the company said.

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