Biocon issues clarification about USFDA inspection
DSIJ Intelligence / 01 Aug 2017
The company has clarified that the USFDA has issued Form 483 observations after an inspection of the plant.
In response to some media queries about the USFDA inspection of its Bengaluru plant, pharmaceutical major Biocon has said that it was a part of the regular periodic audit for a small molecule injectable.
The company has clarified that the USFDA has issued Form 483 observations after an inspection of the plant. Biocon has responded to the regulator with a Corrective and Preventive Action Plan (CAPA) and is on track to implement them in a timely manner, it said.
Biocon was trading at Rs 378.40, down by Rs 6.05 or 1.57% as at 1026 hours on Tuesday, on the BSE. The stock has hit an intraday low of Rs 368.75.