Biocon has announced it received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA) for its Biocon Generics Inc facility in Cranbury, New Jersey. This follows a cGMP inspection conducted between October 6th and 10th, 2025. The VAI status indicates that the FDA will not take regulatory or administrative action.
US FDA Inspection Outcome
Biocon has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (US FDA) following an inspection of its Biocon Generics Inc facility located in Cranbury, New Jersey, U.S. The inspection concluded with a Voluntary Action Indicated (VAI) status.
Details of the Inspection
The cGMP inspection by the agency took place between October 6th and 10th, 2025. The VAI status confirms that, based on the inspection, the FDA does not plan to take regulatory or administrative action at this time.
Source: BSE
