Biocon Biologics Bengaluru drug substance facility classified as VAI
Bengaluru: Biocon has announced that the U.S. Food and Drug Administration (USFDA) has classified Biocon Biologics' Drug Substance Facility at Biocon Campus, (Site 1) located in Bengaluru, Karnataka, as Voluntary Action Indicated (VAI).
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.
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.
Read also: Biocon Foundation Wins 2024 Doing Good for Bharat Award in Healthcare for eLAJ Smart Clinics
"Biocon Biologics remains committed to global standards of Quality and Compliance,” the Company stated.
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.
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.
Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.