Shares of Biocon fell as much as 6.1 per cent to its lowest since January 23. The US health regulator has issued Form 483 to Biocon's Bengaluru facility with 8 observations.
At about 10.05 am, the stock was quoting at Rs 1,019, down Rs 28 or 2.67 per cent.
An FDA Form 483 is issued to companies when the investigator has observed conditions that may constitute violations of the US Federal Food, Drug and Cosmetic Act, 1938.
The stock has gained about 10 per cent this year against 13.8 per cent rise in the NSE index as of Tuesday's close.