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Biocon Biologics' Bengaluru Unit Classified as Voluntary Action Indicated by US FDA

04 Nov 2024
Admin
News Article

Biocon Biologics' Bengaluru Unit Classified as Voluntary Action Indicated by US FDA

Overview

Biocon Biologics said its drug substance facility in Bengaluru has been classified as voluntary action indicated by the US Food and Drug Administration.

Drug Facility Location & Statemenet

The company’s drug substance facility is located at Biocon Campus, (Site 1) in Bengaluru, the company said in a statement.
"This relates to the cGMP inspection conducted by the agency between February 20-28, 2024 and pertains to the supply of rh-Insulin (rhI) drug substance to the United States," it added.

Regarding Regulatory Actions

Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the US FDA.
Biocon Biologics remains committed to global standards of quality and compliance, the company said.