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Biocon Receives Five Observations from US FDA After Bengaluru, India, Unit Inspection

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-- Biocon (NSE:BIOCON, BOM:532523) has received five observations from the US Food and Drug Administration (US FDA) after the pre-license inspection at Biocon's biosimilars site in Bengaluru, India, according to a Thursday filing to the Indian stock exchanges.

The US FDA inspected the unit between April 20 and April 29 and covered three biologics manufacturing units, five quality testing laboratories, and two warehouses.

At the conclusion of the inspection, the U.S. FDA issued a Form 483 with five observations, which the company said are procedural in nature and do not pertain to data integrity or quality oversight.

There were no repeat observations noted, Biocon said.

The company's shares were down over 1% in recent trade.

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