USFDA issues 12 observations for three Biocon units in Malaysia

Biotechnology major Biocon has said US health regulator has issued 12 observations after the inspection of three of its units in Malaysia. Biocon Sdn Bhd’s insulin glargine drug substance, drug product and device assembly facilities in Malaysia underwent a pre-approval inspection by the USFDA between June 24 and July 5, 2019, Biocon said in a filing to BSE.

“The inspection across these three units concluded with 12 observations issued on the Form 483,” a company spokesperson said in a statement.

As per USFDA, Form 483 notifies the company’s management of objectionable conditions after the conclusion of an inspection. “We will respond to the FDA with a corrective and preventive action plan and are confident of addressing these observations expeditiously,” the statement said. The company does not expect any change to its commercialisation plans for insulin glargine in the US, it added. “Biocon remains committed to global standards of quality and compliance,” the statement said. The company, however, did not provide any details about the observations made by the US regulator.