Bangalore-based Biocon on Monday said the US Food and Drug Administration (US FDA) conducted a pre-approval inspection and good manufacturing practice (GMP) examination of its API manufacturing facility and has issued a Form 483, with five observations.
Under the US health regulator, a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“The US FDA conducted a Pre-Approval Inspection (PAI) and GMP inspection of the Active Pharmaceutical Ingredients (API) manufacturing facility of Biocon,” the company said in a filing to the stock exchanges. It added that the inspection of the Bangalore facility took place between January 20-24, 2020.
“We will respond to the FDA with a Corrective and Preventive Action Plan and are confident of addressing these observations expeditiously,” a spokesperson said in a statement.