USFDA Classifies Biocon Biologics' Facility Under Voluntary Action

Biocon Biologics announced that its drug substance facility in Bengaluru received a 'Voluntary Action Indicated' classification from the US FDA. This relates to a cGMP inspection for the supply of rh-Insulin to the US. Despite observed issues, no regulatory action is planned, confirming the company's compliance commitment.

Biocon Biologics announced on Wednesday that the United States Food and Drug Administration has classified its Bengaluru drug substance facility as 'Voluntary Action Indicated'.

The decision follows a cGMP inspection conducted between February 20 and 28, 2024, focusing on the supply of the rh-Insulin drug substance to the US market. The facility, located at Biocon Campus, was found to have some objectionable conditions, yet the USFDA decided not to take immediate regulatory action.

Biocon Biologics affirmed its dedication to maintaining global quality and compliance standards, ensuring that its operations meet the necessary regulatory requirements.

(With inputs from agencies.)