Biocon recently said the United States Food and Drug Administration (USFDA) 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 US health regulator, 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 20-24 January, 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.