Mylan Under Review. Generic drug maker, Mylan Inc.’s manufacturing plant in Morgantown, West Virginia, is being reviewed by the U.S. Food & Drug Administration (FDA) due to alleged “production irregularities,” reported the Pittsburgh Business Times, citing a spokesman.
According to Chris Kelly, an FDA spokesman, the so-called “fact-finding” is considered routine, but could result in further steps, depending on what the review reveals, noted the Pittsburgh Business Times.
Citing the Pittsburgh Post-Gazette, the Pittsburgh Business Times described irregularities at Mylan that included staff “overriding computer-generated warnings about potential quality problems with the drugs” manufactured at the Morgantown plant.
On Sunday, the Post-Gazette reported that internal documents it obtained showed that violations of standard operating procedure were “pervasive” at the West Virginia facility. Mylan’s own report on the violations said the they occurred on all three shifts at the plant, the Post-Gazette said, but did not say how long the unauthorized practices had been going on.
The Post-Gazette also reported that Former FDA inspectors and industry consultants
The Post-Gazette also reported that Former FDA inspectors and industry consultants who reviewed Mylan’s internal report said it “raised troubling questions about the integrity and oversight of the plant’s quality control operations.”
According to the Associated Press, Mylan issued a statement earlier today, asserting that the FDA agreed with its “position that employees at a West Virginia facility did not ignore quality control procedures,” and the charges in the Post-Gazette article were “unfounded”.
But the agency doesn’t see it that way, and just two hours later said it hasn’t reached a conclusion yet, according to the Associated Press. “The investigation is ongoing and the agency has formed no conclusions at this time. Statements to the contrary are untrue,” Steven Solomon, the agency’s assistant commissioner for compliance policy, told the Associated Press.
Mylan is the world’s third largest generic drug company, and its West Virginia plant produces 19 billion doses of medications annually, the Post-Gazette said.
The FDA probe of the West Virginia plant is not the only trouble Mylan has faced recently. According to Reuters, it is also facing a probe at its Matrix Laboratories subsidiary in India by the World Health Organization(WHO) after WHO inspectors found “major deviations” from the organization’s good manufacturing practice. The company corrected some of the problems, WHO said, but other issues remain, Reuters said.