Biocon Litd saw its shares slump nearly 3% on Monday to ₹369.25 after the biopharma giant disclosed its Bengaluru facility was tagged with “VAI status” by the U.S. FDA.
The United States Food and Drug Administration assigns the “vountary action indicated” or VAI tag when it finds conditions or practices at a facility that must be fixed on a voluntary basis by the company but don’t require regulatory intervention at the time.
Such an action is significantly less severe on FDA’s part than when it assigns “official action indicated” or AOI tag, which often results in regulatory crackdown at the facility.
Biocon said the FDA had conducted a surveillance inspection in late September that resulted in this notice.
The facility in question is one of Biocon’s two active pharmaceutical ingredient (API) facilities in Bengaluru, located in the Bommasandra Industrial Area.
The other Bengaluru facility located in Electronic City was also assigned the VAI status in November.
The Kiran Mazumdar-Shaw led company also has three other API plants in India, with two located in Vishakhapatnam and one in Hyderabad.
This stock mover post was first published as a filing recap on Dzambhala Pro at 8:24 pm on Saturday before share price reacted.