Following a USFDA examination of a Malaysian insulin factory, Biocon receives 8 observations

24 Jul 2023 , 11:43 AM

Biopharmaceutical company Biocon Biologics announced on July 21 that the US Food and Drug Administration (FDA) has issued 8 observations at its Insulins Manufacturing Facility in Malaysia.

Following inspections between July 10 and July 20 of this year, the US FDA issued a Form 483, a form that lists breaches.​

If FDA investigators find any circumstances that, in their opinion, may be breaches of the US Food, Drug, and Cosmetic (FD&C) Act and related statutes, they issue a Form 483.

The US drug regulator issued 2 observations for the Delivery Devices unit of Biocon Sdn Bhd, Malaysia, a subsidiary of Biocon Biologics, and 6 observations for the Drug Substance, Drug Product, and Quality Control laboratories.

These observations mostly focus on enhancing operational procedures and bolstering training programmes. The inspections revealed no systemic non-compliance or breaches of data integrity, according to Biocon’s statement to the stock exchanges.

According to its statement, Biocon is certain that it can quickly resolve these observations and is still dedicated to upholding high standards of quality and compliance around the world.

‘We are confident that we can resolve these issues quickly, and we will promptly submit a Corrective and Preventive Action (CAPA) plan to the U.S. FDA. In a statement, a spokesperson for Biocon stated to MoneyControl that the company ‘remains committed to global standards of Quality and Compliance.’

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