Shares of Biocon Ltd. declined as much as 9 percent on Friday, the most in almost a month, after the U.S. drug regulator found ten lapses in quality at the biotechnology company’s Bengaluru plant.
The U.S. Food and Drug Administration issued a Form 483 with 10 observations, published on its website, after an inspection between May 25 and June 3, that BloombergQuint had reported earlier. The regulator’s visit was part of the surveillance audit for a small molecule injectable, a Biocon spokesperson had said in a statement.
The company has responded to the regulator with a correction and prevention action plan (CAPA) and is on track to implement them in a timely manner.Biocon Spokesperson
The stock has fallen 10 times in 12 trading sessions. It is down over 15 percent in two weeks. Biocon trades at a price to earnings ratio of 39.9 times, higher than most of its peers.