Yesterday after market hours, Biocon issued a Press Release stating that the FDA had concluded the pre-approval inspection facility at Bengaluru.
This was for Biocon's insulin drug substance manufacturing facility after its insulin AP/customer submitted this under the ‘New Dru Application.’
The US FDA conducted the inspection between 25th Feb - 5th Mar, 2019.
This has resulted in a Form 483 with six observations.
The FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Obviously, any FDA inspection, that too with observations never goes down well with the market. The stock price fell almost 3% to Rs.608.50, with volumes on the counter going up 2 times. Its 52-week low is at Rs.543.80.