The company today reported that the agency issued a Form 483 with five observations following a preapproval and good manufacturing practices inspection last week. It didn’t say what product it is hoping to get approved for production at the plant or what the issues are but pledged to get on them.
“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,” Biocon said in a statement.
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EDITOR'S NOTE: The story was updated to indicate that the action was taken against Biocon's drug substance plant and not its biosimilar's plant.