USFDA issues Form 483 with 5 observations to Biocon's Bengaluru facility

New Delhi: Biocon Ltd on Monday said the US health regulator conducted a pre-approval inspection and good manufacturing practice (GMP) examination of the API manufacturing facility and has issued a Form 483, with five observations.

As per the USFDA, a Form 483 is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

“The US Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon Ltd,” Biotechnology major said in a filing to BSE.

At the conclusion of the inspection of the Bengaluru facility, which took place between January 20-24, 2020, the agency issued a Form 483, with five observations, the filing said.

“We will respond to the FDA with a Corrective and Preventive Action Plan (CAPA) and are confident of addressing these observations expeditiously. We remain committed to global standards of quality and compliance,” according to company’s spokesperson.

The shares of Biocon were trading at Rs 292.95 a piece on BSE, down 0.51 per cent from the previous close.


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