USFDA classifies Biocon Biologics Biocon Park Site in Bengaluru as VAI

Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) has classified Biocon Biologics' facilities at Biocon Park, Bengaluru, India, as Voluntary Action Indicated (VAI).

This relates to the combined cGMP inspection and Pre-Licensing Inspection (PLI) conducted by the agency between July 15 – 26, 2024.

The inspection scope had included six (6) separate Biologics manufacturing units comprising of four (4) Drug Substance and two (2) Drug Product manufacturing plants as well as five (5) Analytical Quality Control Laboratories, four (4) Microbiology Laboratories, and two (2) Warehouses.

“Biocon Biologics remains committed to global standards of Quality and Compliance,” the Company's spokesperson stated.

Voluntary action indicated means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Medical Dialogues team had earlier reported that the US FDA had concluded a surveillance inspection with four observations at the Biocon's API facility (Site 2), located at Bengaluru, Karnataka.

Read also: Biocon Biologics Bengaluru drug substance facility classified as VAI

Biocon Limited, publicly listed in 2004, is an innovation-led, global biopharmaceutical company. It has developed and commercialized novel biologics, biosimilars and complex small molecule APIs in India and several key global markets, as well as generic formulations in the US and Europe.

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