The inspection scope had included 6 separate Biologics manufacturing units comprising of 4 drug substance and 2 drug product manufacturing plants as well as 5 analytical quality control laboratories, 4 microbiology laboratories, and 2 warehouses.

The USFDA's VAI indicates that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Biocon is an innovation led global biopharmaceuticals company, engaged in the production of therapies for chronic conditions like diabetes, cancer and autoimmune. 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, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development.

The company reported a consolidated net loss of Rs 16 crore in Q2 FY25 as against a net profit of Rs 126 crore in Q2 FY24. Revenue from operations rose by 4% YoY to Rs 3,590 crore during the quarter.