Biocon has recently informed exchanges that its Bengaluru API facility (Site 1) has received a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA). This follows a surveillance inspection conducted from September 16-20, 2024.
The company also confirmed that the inspection has been officially closed, as per 21 CFR 20.64(d)(3), and it has received the Establishment Inspection Report (EIR). The VAI status indicates that while the facility requires some corrective actions, they are not significant enough to impact its operations.
In the exchange filing, Biocon shared, “The Company has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) status from the U.S. Food and Drug Administration (US FDA), for our API facility (Site 1), located at Bengaluru, Karnataka, and the inspection stands closed as per 21 CFR20.64(d)(3)”
In the meantime, Biocon shares opened at ₹332.55, reaching a high of ₹347.70 and a low of ₹332.05 today. The stock’s 52-week high stands at ₹395.80, while its 52-week low is ₹244.55.
