The Food and Drug Administration today said its probe of Mylan Inc.'s generic drug making plant in Morgantown, W.Va., was expected to take another few weeks.
FDA spokesman Christopher Kelly said he could not be more specific about a timeline for completing the investigation into quality control issues at the plant, other that it should be "toward the end of the next few weeks."
The FDA launched the probe at the world's third biggest generic drug company following a July 26 story in the Pittsburgh Post-Gazette citing a Mylan internal report that said workers sidestepped computer-generated warnings about potential problems with the medications they were making. Mylan's report called the quality control breach "pervasive" and "very serious," involving "falsifying information" and "altering product." The breach did not affect the quality of any medications, the report stated.
Mylan Chairman and CEO Robert Coury has repeatedly insisted that the FDA probe was over and that the plant had been cleared despite FDA statements to the contrary.
In a conference call with Wall Street analysts last week Mr. Coury called the matter "a short term distraction." He said regulators had ended their investigation a day after visiting the plant early last week after finding "a minor" problem.
