Did Mylan workers routinely ignore potential quality-control problems at a West Virginia plant? That's what the Pittsburgh Post-Gazette reports today, in a lengthy article based on an internal report obtained by the newspaper. According to the confidential documents, workers in Morgantown, WV, overrode computer-generated warnings of problems on the production line. The violations were "very serious," the report stated (as quoted by the Post-Gazette) and "pervasive." And they'd been going on for at least two years, one worker told company investigators.
Responding to the Post-Gazette story, Mylan said that the procedural violations had "no impact on product quality." A company spokesman told Reuters that Mylan "periodically" faces "deviations" from standard operating procedures. "What sets us apart is the way we've always addressed these issues, swiftly and effectively," the spokesman told Reuters via email.
The potential manufacturing issues at Mylan come at a time when several generics makers have found themselves under FDA scrutiny. Ranbaxy Laboratories had its U.S. imports halted after FDA inspectors found irregularities at one Indian plant. Caraco Pharmaceuticals had more than 30 generic drugs and active ingredients seized by U.S. Marshals last month because of unresolved manufacturing problems.
- see the Post-Gazette piece
- read the story from Reuters