USFDA inspection: Biocon gets 4 observations for 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 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.

Read also: USFDA issues 3 observations for Biocon Visakhapatnam API facility

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.