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Mylan Inc., FDA differ on drug plant slip

July 28, 2009

The U.S. Food and Drug Administration found only a minor deviation in standard procedures at a key Mylan Inc. plant, the generic drugmaker said Tuesday.

But the FDA said its investigation would continue.

The agency’s findings followed a site visit to Mylan’s Morgantown, W.Va., plant after a newspaper report Sunday questioned the company’s quality-control system, a charge Mylan disputed and said the FDA had found baseless.

Aside from a minor standard operating procedures deviation, which Mylan corrected, the FDA determined that the baseless accusations in the article were unfounded,” Mylan said.

However, Steven Solomon, assistant commissioner for compliance policy in the FDA’s Office of Regulatory Affairs, said the agency had formed no conclusions at this time.

Statements to the contrary are untrue, he said in a statement e-mailed to United Press International.

This investigation involves allegations of compliance violations that the FDA takes very seriously, Solomon said.

The Pittsburgh Post-Gazette Sunday cited an internal report saying workers overrode quality controls intended to ensure the safety and efficacy of the company’s prescription drugs.

The newspaper said Mylan’s internal report called the problem pervasive at the plant, which makes an estimated 19 billion doses annually.

Mylan, the world’s No. 3 generic drugmaker, said it contacted the FDA last weekend to notify the agency about the article, and the FDA visited the Morgantown facility Monday.


Source: upi



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