Biocon shares dip 4% on USFDA observations

Shares of biotechnology major Biocon fell by over 4 per cent today after the company received observations from the US health regulator pertaining to issues over manufacturing practices.
The scrip declined 4.06 per cent to close at Rs 1,004.45 on BSE. During the day, it slumped 5.99 per cent to Rs 984.25.
On NSE, the stock went down by 3.98 per cent to end at Rs 1,004.40.
The company's market valuation fell by Rs 851 crore to Rs Rs 20,089 crore.
In terms of volume, 2.32 lakh shares of the company were traded on BSE and over 30 lakh shares changed hands at NSE during the day.

"Biocon has already responded to USFDA (US Food and Drug Administration) on all observations of the recent audit within stipulated timelines," the company said in a regulatory filing this morning.

It was responding to reports that USFDA has issued observations under Form 483 highlighting issues related to quality control tests and sampling during manufacturing at its Bengaluru facility.
As per USFDA, an "FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts".

It notifies the company's management of objectionable conditions.