NEW YORK (Reuters) - Workers at generic drugmaker Mylan Inc overrode quality controls intended to ensure the safety and effectiveness of prescription drugs, according to an internal report obtained by the Pittsburgh Post-Gazette newspaper.
The report said the practice of violating government-mandated quality control procedures was “pervasive” and had occurred on all three shifts at the company’s plant in Morgantown, West Virginia, which makes roughly 19 billion doses of medication annually, the Post-Gazette reported.
The newspaper reported that Mylan has launched a probe into the matter.
Mylan spokesman Michael Laffin said in an email to Reuters on Sunday that the issue cited in the Post-Gazette had “no impact on product quality whatsoever.” Laffin said that like any manufacturing facility, Mylan “periodically” faces “deviations” in standard operating procedures.
“What sets us apart is the way we’ve always addressed these issues, swiftly and effectively,” Laffin wrote.
Spokespeople for the Food and Drug Administration did not respond to messages left by Reuters seeking comment.
The Post-Gazette reported that it was unclear exactly how long employees had been ignoring so-called “red screens,” alerts triggered during the making of tablets and capsules that warn production workers that the medication may not meet specifications
“I’ve never before seen anything like this, that has reached this level of cheating,” James Akers, a longtime pharmaceutical industry consultant in Kansas City, Missouri, told the Post-Gazette. “It certainly indicates a significant problem within their company.”
Experts interviewed by the newspaper, who reviewed the internal report, said there was not enough information to judge whether any drugs going out the door had been compromised.
Reporting by Steve Eder; Editing by Leslie Adler