News article calls Mylan’s quality control into question; company responds

7/27/2009

PITTSBURGH A news article published over the weekend calling generic drug maker Mylan’s manufacturing into question has drawn a response from the company.

The Pittsburgh Post-Gazette reported Sunday that workers at the company’s Morgantown, W.Va., plant overrode drug quality controls required by the government by ignoring and deleting computer warnings of possible drug quality or equipment problems, based on a confidential internal report obtained by the newspaper’s reporters that called it a “pervasive” problem. Normally the warnings, known as “red screens,” require production to halt until a quality-control agent can investigate the matter.

The company responded by saying in a statement Monday that the Post-Gazette article was based on anonymous sources, improperly obtained documents and third-party commentary.

“Our customers and stakeholders can rest assured that whenever there is even the slightest departure from [a standard operating procedure], it will be dealt with immediately and effectively,” the company said in a statement. “This issue had no impact on the quality of our product.”

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