USFDA issues 3 observations for Biocon Visakhapatnam API facility
Bangalore: Biocon has informed in a BSE filing that the U.S. Food and Drug Administration (USFDA) has concluded a GMP inspection with three observations at the Company’s API facility (Site 6), at Visakhapatnam, Andhra Pradesh.
The inspection was completed on 14 June 2024.
“Three 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 stated in a BSE filing.
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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.
