USFDA classifies Biocon Biologics’ Drug Substance facility as Voluntary Action Indicated

 Bengaluru: The US drug regulator US Food and Drug Administration (FDA) has classified Biocon Biologics’ Drug Substance Facility at Biocon Campus, in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).

“The U.S. Food and Drug Administration (FDA) has classified Biocon Biologics’ Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).   This relates to the cGMP inspection conducted by the agency between February 2028, 2024 and pertains to the supply of rh-Insulin (rhI) Drug Substance to the United States.   Biocon Biologics remains committed to global standards of Quality and Compliance.”

In the context of the FDA “voluntary action indicated” (VAI) refers to a classification that the FDA may assign following an inspection. This status means that the FDA has observed some issues or deficiencies in the inspected entity’s operations, but these issues are not severe enough to warrant regulatory action, such as a warning letter or enforcement action. Instead, the FDA expects the facility to address these issues on their own, voluntarily, to ensure compliance with applicable regulations.

The VAI classification generally signals to the inspected company that while improvements are needed, they are trusted to take corrective measures without further intervention from the FDA. If a company fails to address these issues adequately, however, the FDA might reclassify the status and escalate the response to ensure compliance.