Biocon slips on FDA 'observation'

about 2 years ago
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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.

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