USFDA inspection: Biocon gets 4 observations for Visakhapatnam API facility

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-06-24T14:15:02+05:30 | Updated On 24 Jun 2024 2:15 PM IST

Bangalore: Biocon has informed in a BSE filing that the U.S. Food and Drug Administration (USFDA) has concluded a GMP inspection of the Company's API facility (Site 5), located at Visakhapatnam, Andhra Pradesh with 4 observations.

The inspection was completed on June 21, 2024.

"Four observations were cited at the end of the Inspection, which we will be addressing within the stipulated time. Biocon stands committed to Quality, Safety & Efficacy of the products manufactured,” the Company informed.

Medical Dialogues team had earlier reported that USFDA had concluded a GMP inspection with three observations at the Company's API facility (Site 6), at Visakhapatnam, Andhra Pradesh.

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.

bioconbiocon newsUSFDAUSFDA inspection

Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751