Biocon's Cranbury facility in US receives VAI status in FDA inspection

Biotechnology major Biocon Ltd on Thursday (December 18) said it has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the US Food and Drug Administration (FDA) for its Biocon Generics Inc facility in Cranbury, New Jersey, US.

The inspection was conducted by the FDA between October 6-10, 2025, under current Good Manufacturing Practice (cGMP) regulations.

What is an Establishment Inspection Report (EIR)?

Based on the inspection and the response given by the company to the FDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection. The EIR reflects the FDA’s official determination of a factory’s GMP compliance.

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The FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications. The three classifications displayed are:

No Action Indicated (NAI):

Given if no violations were observed. The facility can continue selling approved drugs and will also receive approvals for new filings.

Voluntary Action Indicated (VAI): Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals for new filings.

Official Action Indicated (OAI): Given that violations found on-site require further administrative sanctions and mandatory corrective actions.

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Shares of Biocon Ltd ended at ₹391.50, up by ₹5.40, or 1.40%, on the BSE today, December 18.