Biocon receives EIR with VAI from USFDA

6 Aug 2024 , 01:26 PM

Biocon has announced that it has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) from the United States Food and Drug Administration (USFDA) for their API facility (Site 5), which is located in Visakhapatnam, Andhra Pradesh.

Voluntary action indicated (VAI) indicates that unacceptable conditions or practices were discovered, but the government is not prepared to take or suggest any administrative or regulatory action.

This is based on the agency’s GMP inspection conducted between June 17th and 21st, 2024.

“Biocon remains committed to the quality, safety, and efficacy of its manufactured products,” the company wrote in a BSE filing.

Biocon Limited, which went public in 2004, is a multinational biopharmaceutical firm that prioritises innovation. It has created and marketed new biologics, biosimilars, and complicated small molecule APIs in India and other significant worldwide markets, as well as generic formulations in the United States and Europe.

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