Biocon’s Andhra facility gets VAI from USFDA

6 Aug 2024 , 12:38 PM

Biotechnology firm Biocon Ltd announced on Monday (August 5) that it had obtained an establishment inspection report (EIR) with voluntary action indicated (VAI) from the US Food and Drug Administration (FDA) for its active pharmaceutical ingredient (API) facility in Visakhapatnam, Andhra Pradesh.

According to a stock exchange filing, the Company has received an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) from the United States Food and Drug Administration (USFDA) for our API facility (Site 5) in Visakhapatnam, Andhra Pradesh.

This follows the agency’s good manufacturing procedures (GMP) examination from June 17-21, 2024. Biocon reaffirmed its commitment to maintaining the highest levels of quality, safety, and efficacy in its products.

“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 products,” the business stated.

Based on the inspection and the company’s answer to the US FDA, the latter issues an EIR within 30 days of inspection. The EIR documents the FDA’s official determination of a factory’s GMP compliance.

This is issued when infractions are discovered but the issues do not warrant more regulatory action. Improving GMP compliance is entirely voluntary in this scenario. The facility can continue to sell approved pharmaceuticals while also receiving approvals for new filings.

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